1. health and fitness
2. disease
3. incontinence

Committee 10 C
Conservative Treatment in Women
Chairman
P. D. WILSON (New Zealand)
Members
K. BO (Norway),
J HAY-SMITH (New Zealand),
I. NYGAARD (USA),
D. STASKIN (USA),
J. WYMAN (USA),
Consultant
A. BOURCIER (France)
571
CONTENTS
Chapter 10C
I. INTRODUCTION
V. ANTI-INCONTINENCE DEVICES
IN THE FEMALE PATIENT
II. LIFESTYLE INTERVENTIONS
1. INTRODUCTION
2. DEVICES THAT TREAT INCONTINENCE SECONDARY TO FAILURE TO EMPTY (DETRUSOR
UNDERACTIVITY / OUTLET OVERACTIVITY) IN
THE NON-NEUROGENIC ADULT FEMALE
3. DEVICES THAT TREAT FAILURE TO STORE
(OUTLET UNDERACTIVITY) IN THE NON-NEU-
1 BACKGROUND
2. WEIGHT LOSS
3. PHYSICAL FORCES (EXERCISE, WORK)
4. SMOKING
5. DIETARY FACTORS
6. CONSTIPATION
7. OTHER
ROGENIC
AMBULATORY ADULT
FEMALE
POPULATION
4. BLOCKAGE
III. PHYSICAL THERAPIES
OF
URINARY
OCCLUDING EGRESS
1. INTRODUCTION
2. PELVIC FLOOR MUSCLE TRAINING
(PFMT)
3. BIOFEEDBACK AND/OR INTRAVAGINAL
RESISTANCE
4. ELECTRICAL STIMULATION
5. WEIGHTED VAGINAL CONES
6. OTHER FACTORS AFFECTING OUTCOME
7. PREVENTION
LEAKAGE
BY
- OCCLUSIVE DEVICES
VI. GENERAL CONCLUSIONS &
SUMMARY OF
RECOMMENDATIONS
1. REGARDING LIFESTYLE INTERVENTIONS
2. REGARDING PHYSICAL THERAPIES
3. REGARDING BLADDER RETRAINING
4. REGARDING ANTI-INCONTINENCE DEVICES:
VII: RECOMMENDATIONS FOR
FUTURE RESEARCH
IV. BLADDER RETRAINING
1. LIFESTYLE INTERVENTIONS
2. PHYSICAL THERAPIES
3. BLADDER RETRAINING
4. DEVICES
1. INTRODUCTION
2. BLADDER RETRAINING
3. BLADDER RETRAINING IN COMBINATION
WITH OTHER ADJUNCTS (PELVIC FLOOR
MUSCLE TRAINING AND MEDICATIONS)
4. FACTORS AFFECTING OUTCOMES OF BLAD-
APPENDIX 1
1. SEARCH STRATEGIES
2. ACKNOWLEDGEMENTS
DER RETRAINING
5. ADVERSE EFFECTS ASSOCIATED WITH BLADDER RETRAINING
572
Conservative Treatment in Women
P. D. WILSON,
K. BO, J HAY-SMITH, I. NYGAARD, D. STASKIN, J. WYMAN,
A. BOURCIER
and recommendations on efficacy made on the best
available level of evidence reviewed. (see Introduction
to Management Chapters Reference É..)
I. INTRODUCTION
Conservative treatment is any therapy that does not
involve pharmacological or surgical intervention. In
women, it includes principally, lifestyle interventions,
physical therapies, bladder retraining (all encompassed
by the term Òbehavioural therapyÓ used in some countries) and anti-incontinence devices. On the whole these
treatments are simple, low cost remedies with a low
risk of adverse effects and do not prejudice other subsequent treatment options. As the prevalence of female
urinary incontinence is high, and with the current
constraints on the healthcare economy, conservative
treatment constitutes the principal form of management
at primary care level. It is the first line of treatment for
women with stress and/or urge incontinence. It is also
indicated for those women for whom other treatments,
in particular surgery, are inappropriate, for example,
those who are unwilling to undergo or who are not
medically fit for surgery, and those who plan future pregnancies (as these may adversely affect surgery). Other
indications include patients awaiting or who wish to
delay surgery and women whose symptoms are not
serious enough for surgical intervention.
To date, only a relatively small number of objective
clinical comparative studies with large numbers have
been carried out to assess the effectiveness of conservative treatment.
II. LIFESTYLE INTERVENTIONS
1 BACKGROUND
Various lifestyle factors may play a role in either the
pathogenesis of, or later, the resolution of incontinence.
While published literature about lifestyle factors and
incontinence is sparse, alterations in lifestyle are frequently recommended by health care professionals and
lay people alike. However, to date, most studies about
lifestyle report associations only and do not assess the
actual effect of applying or deleting the behaviour in
question on incontinence. Currently, only a relatively
small number of randomized trials have been carried
out to assess the effect of a specific lifestyle on incontinence. This section will examine the evidence for the
association and use of lifestyle interventions in the
management of female urinary incontinence. A summary of the search strategy and inclusion/exclusion criteria is given in Appendix 1.
To date, however, only a relatively small number of
objective clinical comparative studies of adequate
patient numbers have been carried out to assess the
effectiveness of conservative treatment of urinary
incontinence. This chapter reviews the main types of
conservative treatment particularly with regard to their
effectiveness. This information assists the counselling
of neurologically ÒnormalÓ adult women regarding
these treatment options (readers are directed to the
chapters on men, children, the elderly and neuropathic
patients for discussion on the effect of these conservative treatments in these specific groups). A systematic
review of the literature has been carried out, comment
made on the quality of all relevant studies identified,
Regarding lifestyle interventions, most studies to
date have reported associations only and have not
assessed the actual effect of applying or removing
the behaviour in question.
2. WEIGHT LOSS
a) Quality of data
1 Two prosOne randomized pilot study was found [1].
573
c) Summary
pective cohort studies [2],[3]
2 3 evaluated the effect of
weight loss. Other study designs were cross-sectional,
retrospective cohort, or case-control studies.
Obesity is an independent risk factor for the prevalence
of urinary incontinence. Massive weight loss significantly decreases incontinence in morbidly obese
women. Preliminary evidence suggests that moderate
weight loss may also result in decreased incontinence.
(Level of Evidence: 1/2).
Sample sizes for the interventional trials were 12 [2],
2
[3],
1 Sample sizes for studies which assessed
3 and 10 [1].
the association between obesity and incontinence, but
in which no intervention was done, ranged from 193 [4]
4
to 7949 [5].
5 The case control study had a sample size of
108 cases and 108 controls [6].
6
d) Recommendation
Weight loss is an acceptable treatment option for morbidly obese women. At this time, there is scant information on whether weight loss resolves incontinence in
women who are moderately obese. At least one such
larger trial is now ongoing. Based on the current evidence, maintaining normal weight through adulthood
may be an important factor in the prevention of the
development of incontinence. Given the high prevalence of both incontinence and obesity in women, the dual
issues of weight loss and prevention of weight gain
should receive high research priority.
The outcome measure in all studies with the exception
of Bump [2]
1 was subjective, as determi2 and Subak [1]
ned by a self-administered questionnaire. Bump also
utilized objective measures including urodynamics,
bladder diary and standardized fluid loss quantification
test. Subak also utilized a 7-day urinary diary.
Follow-up periods for the interventional studies were
one year after gastroplasty surgery [2]
2 , 6 months after
completion of weight reduction, either by means of low
calorie liquid or reduced calorie solid diet [1]
1 and not
stated [3].
3
b) Results
GRADE OF RECOMMENDATION: B
Many researchers [7],
6 [8]
5
7 [6],
8 [9],
9 [4],
10 [11],
11 [5]
4 [10],
and [12]
12 reported an association between increased
weight, or increased body mass index, and urinary
incontinence. This association held after controlling for
age and parity. In one multivariate analysis, Brown [11]
11
reported that the prevalence of daily incontinence
increased by an odds ratio of 1.6 per 5 BMI (body mass
index, kg/m2) units. In a multivariate analysis of a dif5 found that the prevalence
ferent population, Brown [5]
of at least weekly stress incontinence increased by 10%
13
(OR 1.1) per 5 units BMI. Similarly, Foldspang [13]
reported an odds ratio of 1.07 for incontinence prevalence per BMI unit, after controlling for other factors.
Obesity is an independent risk factor for urinary
incontinence. There is level 2 evidence that weight
loss in morbidly obese women decreases incontinence, and scant preliminary level 1 evidence that moderately obese women who lose weight have less
incontinence than those who do not.
3. PHYSICAL FORCES (EXERCISE, WORK)
a) Quality of data
No randomized trials exist in which incontinence prevalence is compared between subjects assigned to
heavy work or high impact activity versus sedentary
activities. One case-control study compared the incidence of surgery for incontinence and/or prolapse [15],
15
while a second compared nulliparous women with and
without stress incontinence symptoms [16].
16 B¿ [17]
17
18 evaluated the difference in incontiand Nygaard [18]
nence prevalence between women engaged in high ver19 described a series
sus low impact activities. Davis [19]
of women who became incontinent after parachute jumping. In a retrospective cohort study, Nygaard [18]
18
compared incontinence prevalence in high-impact ver20 compared
sus low-impact former athletes. B¿ [20]
incontinence prevalence between Norwegian Olympians and controls.
2 [3]
Two groups [2],
3 reported resolution of incontinence
in the majority of cases after massive weight loss in
morbidly obese women undergoing surgical weight
reduction procedures. While obesity is commonly
considered a risk for stress incontinence, in BumpÕs [2]
2
study, women with urge incontinence were as likely to
experience post-operative continence as women with
stress incontinence. In SubakÕs [1]
1 pilot study of 10
women, all six of the women achieving a weight loss of
at least 5% had at least a 50% reduction in incontinent
episodes compared to one out of the four women with
<5% weight loss.
In a cross-sectional study of 1800 `Swedish women
14 15% incontinent women reported at least a 5 kg
[14],
weight loss in the preceding 5 years, compared to 11%
of continent women (p=.05). This may be secondary to
intentional weight loss as a treatment for urinary incontinence, rather than some effect of weight loss itself.
Sample sizes range from 144 [18]
18 to 305 [17]
17 for the
19
cohort studies. One case series had nine subjects [19].
The population-based case control study compared
28,619 cases with 1,652,533 controls. The recent study
574
by B¿ [17]
17 compared 572 athletes, ages 15-39 years,
with 574 controls.
employed in various occupations that require heavy lifting and the paucity of scientific data about the association of such exertions and incontinence, this association
should be investigated further. Specifically, research
must establish whether heavy exertion is an etiologic
factor in the pathogenesis of incontinence, and whether
changing exertions can alleviate established incontinence.
b) Results
Minimal stress incontinence is common in young exercising women [21],
21 [17],
17 [16].
16 College athletes participating in high impact activities are more likely to report
the symptom of stress incontinence during exercise
than those participating in low impact exercise [18].
18 B¿
[20]
20 found no difference in incontinence prevalence
between elite athletes and controls. However, the prevalence of stress and urge incontinence symptoms was
higher in athletes who had a diagnosed eating disorder
than those without such a diagnosis. There is little available information on whether strenuous exercise or
activity causes the condition of incontinence later in
life. In a study which questioned women who were
Olympians approximately 25 years ago, those who
competed in gymnastics or track and field were not
more likely to currently report daily or weekly incontinence than Olympians who competed in swimming
22 Nygaard 1997. Certain provocations may cause
[22]
stress incontinence: a recent report described nine nulliparous infantry trainees who developed stress incontinence and pelvic floor defects for the first time during
airborne training, which included parachute jumping
[19].
19 The precise number of total trainees is unknown
but is estimated to be approximately 500.
GRADE OF RECOMMENDATION: C
There is scant level 2 and 3 evidence that suggests
that active women may be more likely to report
incontinence than sedentary women, and that heavy
occupational work may be associated with pelvic
organ prolapse and urinary incontinence. However,
there are no trials that assess the role activity plays in
treating urinary incontinence.
4. SMOKING
a) Quality of data
One case-control study compared incontinent smokers
with incontinent non-smokers [23],
while a second
23
compared smoking behaviour between continent and
incontinent women [24].
24 Three large cross sectional
studies evaluated multiple risk factors for incontinence,
25
including smoking [11],
[25],
[26].
11
26 In vitro studies
assessed the effects of nicotine on bladder muscle
contraction.
Surprisingly little information is available on the relationship between stressors in the workplace and urinary incontinence. Danish nursing assistants, who are
exposed to frequent heavy lifting, were 1.6 fold more
likely to undergo surgery for genital prolapse and/or
incontinence than women in the general population; the
study did not control for parity nor weight [15].
15
Sample sizes were 189 [23],
23 160 [24],
24 7949 [11],
11 7338
[26],
26 and 1761 [25].
25
b) Results
Strenuous exercise is likely to unmask the symptom of
stress incontinence during the provocation. There is no
evidence that strenuous exercise causes the condition of
incontinence. In a small number of women without
other known risk factors, extreme provocations such as
parachute jumping may cause incontinence. There is
scant uncontrolled data that suggests that women engaged in occupations with heavy lifting may be predisposed to genital prolapse and/or incontinence. (Level of
Evidence: 2/3). The data is insufficient to draw any firm
conclusions. In spite of the fact that healthcare professionals commonly advise restricting exercise and heavy
lifting following incontinence or prolapse surgery, there
is no published evidence that this improves surgical
outcome.
Smokers were more likely to report incontinence than
26 but not in two
non-smokers in two studies [24],
24 [26],
others [11],[25].
11 25 After adjusting for age, parity, type of
delivery, and pre-pregnancy BMI, smokers had a 1.3
fold higher risk (95% CI 1.0-1.8) of reporting inconti26
nence at 16 weeks gestation than non-smokers [26].
Incontinent smokers were found to have stronger urethral sphincters and lower overall risk profiles than
23 therefore, it was propoincontinent non-smokers [23]
sed that more violent coughing promotes anatomic
defects which allow incontinence. In potential support
of nicotine as a risk factor for incontinence, Hisayama
and Koley [27]
27 found that nicotine produces phasic
contraction of isolated bladder muscle probes in vitro.
However, Milson [28]
28 reported an apparent paradoxical
local estrogenic effect of nicotine on the vagina, resulting in a decrease in vaginal pH and an increase in lactobacilli.
d) Recommendations
c) Summary
Given the large proportion of women who are
The data relating to the association of smoking and
c) Summary
575
incontinence is conflicting. Smokers may have a different mechanism causing their incontinence than nonsmokers (Level of Evidence 3/4). No data has been
reported examining whether smoking cessation
resolves incontinence.
initial group of adults enrolled in the randomized trial
29 subjects who reduced caffeine intake to <100 mg
[29]
per day decreased daily incontinent episodes by 74%
compared to a 32% reduction in those who continued
normal caffeine intake during the one-month study period. No difference was seen in urgency or number of
voids between the groups (though, as noted, the final
sample size has not yet been achieved). In a multivariate analysis, [11]
11 found no association between coffee
drinking or alcohol drinking and daily incontinence.
d) Recommendations
Further prospective studies are needed to determine
whether smoking cessation prevents the onset, or promotes the resolution, of incontinence.
¥ Decrease fluid intake:
GRADE OF RECOMMENDATION: C.
In a geriatric population, there was a strong relationship
between evening fluid intake, nocturia, and nocturnal
voided volume; this relationship was weaker for diurnal
33 In incontinent women over age
intake and voiding [33].
55 years, there was a modest positive relationship between fluid intake and severity of incontinence in
women with stress incontinence; fluid intake accounted
for 14% of the explained variability in number of
34
incontinent episodes [34].
No such correlation was
found in women with detrusor overactivity. In a rando36 32 women were assigned to one of
mized trial [36],
three groups: increase fluid intake by 500 cc over baseline, decrease by same amount, or maintain baseline
level. While non-adherence to the protocol made results
difficult to interpret, the authors reported that 20
women who had fewer incontinent episodes at the end
of the trial attributed this to drinking more fluids.
No data has been reported examining whether smoking cessation resolves incontinence.
5. DIETARY FACTORS
a) Quality of evidence
Preliminary results (in abstract form) of a randomized
trial on the effects of caffeine upon frequency, urgency
29 One randomiand urge incontinence are available [29].
zed trial has assessed the efficacy of fluid management
in the treatment of incontinence. No randomized trial
was identified that addressed dietary changes.
One study compared women with detrusor overactivity
with continent women who received caffeine tablets
30 while another compared caffeine intake between
[30],
women with detrusor overactivity and those without
[31].
31 The effect of decreasing caffeine intake in a small
cohort of incontinent women was examined in a prospective fashion [32].
32 One large epidemiologic trial analyzed the effect of coffee drinking in a multivariate
fashion [11].
11
¥ Alcohol:
After adjusting for age and gender, no association was
found between urinary incontinence and consumption
of alcohol [35].
35
¥ Diet:
Sample sizes were: 26 [29]
29 (target sample size is 90
subjects); 30 [30],
30 128 [33],
34 7949 [11],
11 6037
33 126 [34],
[35],
159
[31],
and
34
[32].
31
35
32
Anecdotal evidence suggests that eliminating dietary
factors such as artificial sweeteners and certain foods
may play a role in continence.
b) Results
c) Summary
¥ Caffeine:
Fluid intake plays a minor, if any, role in the pathogenesis of incontinence. The data on caffeine intake and
incontinence are conflicting. While large cross-sectional surveys indicate no association, small clinical trials
do suggest that decreasing caffeine intake improves
continence (Level of Evidence: 2/3).
Following caffeine intake, women with detrusor overactivity had increased detrusor pressure on bladder
filling, while continent women had no such abnormality [30].
30 In a population of 259 consecutive women pre31 131 women with detrusor
senting for urodynamics [31],
overactivity had a significantly higher mean caffeine
intake (484 +/- 123 mg/day) than women without this
diagnosis (194 +/- 123 mg/day). This association persisted after controlling for age and smoking. In 34
women with symptoms of urinary incontinence (mostly
mixed) who decreased caffeine intake (from 900
mg/day to 480 mg/day), episodes of daily urine loss
also decreased (from 2.33 to 1.0 per day) [32].
32 In the
d) Recommendations
Given the fact that decreasing fluids may lead to urinary tract infections, constipation, or dehydration, this
intervention should be reserved for patients with abnormally high fluid intakes.
Caffeine consumption is pervasive in many societies
and may play a role in exacerbating urinary incontinen-
576
c) Summary
ce. Larger randomized trials to assess the effect of caffeine and other dietary factors are feasible and important.
There is fair data to suggest that chronic straining may
be a risk factor for the development of incontinence.
(Level of Evidence:2/3). There are no intervention
trials that address the effect of resolving constipation on
urinary incontinence.
GRADE OF RECOMMENDATION: B
Fluid intake would appear to play a minor, if any,
role in the pathogenesis of incontinence.
d) Recommendations.
Level 2 and 3 evidence is conflicting on whether caffeine intake is associated with urinary incontinence.
There is scant level 1 evidence that decreasing caffeine improves continence.
Further research is needed to delineate the role of straining in the pathogenesis of incontinence. If the association holds, public education, particularly of parents and
pediatricians, is needed to make an impact on the common problem of straining in children.
6. CONSTIPATION
GRADE OF RECOMMENDATION: C
a) Quality of data
Chronic straining may be a risk factor for pelvic
organ prolapse and urinary incontinence
No published trials were found which assess the effect
of regulating bowel function on incontinence. An
observational study compared the self-report of straining as a child with urogynecologic symptoms as an
adult. Population-based studies assessed multiple risk
factors for incontinence [37],
37 [38].
38
(level 2 and 3 evidence). No intervention trials have
examined the impact of resolving constipation on urinary incontinence.
7. OTHER
Sample sizes range from 73 for the observational study
39 to 213 in a study correlating the surrogate mea[39]
sures of perineal descent and pudendal neuropathy [40]
40
to 1154 and 1051 in the population-based studies [37],
37
[38]
38 respectively.
a) Quality of data
One study rigorously assessed urine loss during various
postural changes (crossing legs and bending forward)
[42].
42 No study has evaluated whether postural changes
are a satisfactory form of treatment outside of the laboratory setting. Timed voiding and relaxation techniques, particularly for urge incontinence, are discussed
in (ChapterÉ). There are many other lifestyle interventions suggested either by health care professionals or
the lay press for the treatment of urinary incontinence,
including reducing emotional stress, wearing non-restrictive clothing, utilising a bedside commode, decreasing lower extremity edema, treating allergies and
coughs, wearing cotton underwear, and increasing
sexual activity. These interventions are, however, all
anecdotal in nature.
b) Results
In a small observational study, 30% of women with
stress incontinence and 61% of women with uterovaginal prolapse reported straining at stool as a young adult,
compared to 4% of women without urogynecologic
symptoms [39].
39 In a large population-based study of
1154 women over age 60 years, those with urinary
incontinence were slightly more likely to report constipation than those who were continent of urine (31.6%
vs 24.7%) [37].
37 After adjusting for demographic and
obstetric confounders, women who reported straining at
stool were 1.9 times (95% CI 1.3, 2.6) and 1.7 times
(95% CI 1.2, 2.4) more likely to report stress inconti38 There appears to
nence and urgency, respectively [38].
be an association between straining and pudendal nerve
function. The mean pudendal nerve terminal motor
latency (PNTML) increased after straining, correlated
with the amount of descent, and returned to resting by
41 Others found evidence
four minutes after a strain [41].
of pudendal neuropathy in only 25% of women with
abnormal perineal descent; in this large group of
patients with defecating dysfunction no relationship
was seen between neuropathy and pelvic descent, leading to the conclusion that pelvic descent and neuropa40
thy may be two independent finding [40].
b) Results
Postural changes: Urine loss during provocations can
be significantly decreased by crossing the legs or by
crossing the legs and bending forward [42].
42
c) Summary
There is no scientific evidence about whether other lifestyle changes except for some postural changes, affects
either the treatment of, or the prevention of, urinary
incontinence. (Level of Evidence 2/3).
d) Recommendations
As various lifestyle interventions are recommended by
577
physicians, studies evaluating the effect of implementing these factors on incontinence are warranted. While
some lifestyle changes may prove beneficial for individual patients, it is unlikely that manipulating these factors will have a major effect on the overall incontinence problem.
logical rationale for the use of PFMT in the management of stress incontinence is based on the reasoning
that a strong and fast pelvic floor muscle (PFM)
contraction will clamp the urethra, increasing the urethral pressure and preventing leakage during an abrupt
increase in intra-abdominal pressure[46].
DeLancey
46
47 has also suggested that an effective contraction of
[47]
the PFM may press the urethra against the pubic symphysis, creating a mechanical pressure rise. The timing
of the pelvic floor muscle contraction may also be
important. It has been suggested that a well-timed, fast
and strong PFM contraction may prevent urethral des48
cent during abrupt intra-abdominal pressure rise [48]
and there is some evidence that the PFM ÒreflexÓ
contraction is a feed-forward loop, as it may precede
49
the bladder pressure rise by 200-250 milliseconds [49].
GRADE OF RECOMMENDATION: C.
There is level 2 evidence that postural changes may
decrease urinary incontinence. There is no evidence
whether other such lifestyle changes decrease urinary incontinence.
III. PHYSICAL THERAPIES
50 have demonstrated that voluntary
Miller et al [50]
contraction of the PFM before or during cough can
effectively prevent urinary leakage after only a week of
training. However in healthy continent women, cocontraction of the pelvic floor muscles before or during
physical exertion is an automatic response and does not
require conscious effort. Pre-contractions may be possible before single bouts of physical exertion but it is
unlikely that women would be able to voluntarily
contract the PFM throughout prolonged activities such
as running or dancing. Therefore one aim of PFMT is to
build the muscles to reach the automatic response level.
1. INTRODUCTION
Graded muscle training alone, or in combination with
other physical adjuncts such as biofeedback, electrical
stimulation, and vaginal cones, is used to rehabilitate
and strengthen the pelvic floor muscles. The physical
therapy (physiotherapy) profession has a long tradition
in the use of these physical agents for the prevention
and treatment of incontinence [43],[44].
43 44
This section will examine the evidence for the use of
pelvic floor muscle training with and without adjuncts,
electrical stimulation and vaginal cones in the prevention and management of adult female stress, urge and
mixed urinary incontinence, and makes recommendations for effective treatment based on the findings. In
order to present the best possible evidence and in an
attempt to differentiate specific treatment effects from a
host of other variables the review is restricted to the findings from systematic reviews of randomised clinical
trials (RCTs), or the findings of RCTs where systematic
reviews were not available. A summary of the search
strategy used to identify systematic review and randomised trial reports is given in Appendix 1.
The objective of PFMT in the management of stress
incontinence is usually to improve strength and/or
timing of the pelvic floor muscle contraction. Regular
strength training increases the number of activated
motor units, frequency of excitation (neural adaptation)
and muscle volume (hypertrophy) [51],
51 [52].
52 However,
muscle fiber hypertrophy is a slow process and begins
only after regular and intense strength training for more
than eight weeks [52].
52 With increased resistance, training hypertrophy may continue for years and a prolonged training period is needed to increase muscle volume.
As the focus of this section was to present the evidence
on the effect of physical therapies in neurologically
ÔnormalÕ adult women, readers are directed to the chapters on men, children, the elderly, and neuropathic
disorders for discussion on the effects of physical therapies in these specific groups.
The use of PFMT (or voluntary pelvic floor muscle
contraction to control urge as part of a bladder training
program) in the management of urge incontinence has a
less substantial biological rationale. Godec et al
demonstrated reflex inhibition of the detrusor muscle
with an electrically stimulated contraction of the PFM.
55 have
54 and Morrison [55]
53 De Groat [54]
Godec et al [53],
both shown inhibition of the detrusor by unconscious
contraction of the PFM experimentally. It has been suggested that reflex inhibition of detrusor contractions
may accompany repeated voluntary pelvic floor muscle
contraction or maximum contractions [44],
44 [48],
48 [56].
56
2. PELVIC FLOOR MUSCLE TRAINING
(PFMT)
a) Background
In 1948 Arnold Kegel reported on the successful treatment of 64 cases of female urodynamic stress incontinence using pelvic floor muscle exercises, with a per45 The bioineometer for resistance and biofeedback [45].
For the purposes of this review PFMT was defined as
any program of repeated voluntary pelvic floor muscle
578
contraction taught by a health care professional. This
definition includes variations in the purpose of PFMT
(e.g. PFMT for strengthening or urge suppression), the
teaching of PFMT (e.g. individual or group teaching),
the types of contractions (e.g. quick or held), and the
number of contractions per day, etc.
¥ Random allocation concealment
Of the 31 trials contributing to this section, random
allocation concealment was adequate in five [63],
63 [64],
64
65
7
66 and probably inadequate in two [67],
[65],
[7],
[66]
67
68 and in the remainder it was either unclear if allo[68],
cation was adequately concealed, or the authors stated
simply that allocation was at ÒrandomÓ.
Pelvic floor muscle training has been used in preference to other previously used terms such as KegelÕs exercises, pelvic exercises, pelvic floor exercises and pelvic
floor muscle exercises. The use of the term KegelÕs
exercises no longer seems appropriate as current practice is very different to the program originally suggested
45 Descriptions that fail to include
by Kegel in 1948 [45].
the word muscle seem equally inappropriate, as it is the
muscular component of the pelvic floor that is the focus
of any exercise program. Any term used should also
state that the pelvic floor muscles, not the pelvic
muscles in general, are the targets of the intervention.
Further, the authors of this sub-chapter suggest that the
use of the term training is more appropriate than exercise as exercise is commonly interpreted as one episode of training whereas training means repeated exercise over time. The effect of training is dependent on four
factors; the type of exercise, frequency, intensity and
57 The dose response
duration of the training period [57].
curve for training suggests that there is a baseline (or
floor) below which training is ineffective, and an upper
limit (or ceiling) above which over-training syndromes
58 The use of the term pelvic floor muscle
are created [58].
training (PFMT) is proposed and used throughout.
¥ Masking of participants and assessors
As in any physical intervention it can be difficult or
impossible to adequately mask participants to the inter69 a comparison of PFMT and
vention. Only one trial [69],
placebo PFMT, attempted this. Masking of outcome
assessors was clearly stated in nine of the 31 trials [64],
64
[70],
70 [71],
71 [68],
68 [50],
73 69 [66].
72 [73],[69],
66 Two trials
50 [72],
stated that outcome assessors were not masked [74],
74
[75]
75 and in the remainder this was not reported.
¥ Sample size and power calculation
In six trials the size of the study population was based
67 [22],
64 [67],
75
63 [64],
22 [66],
66 [75].
on a power calculation [63],
Six trials randomised more than 50 women to each
73 [76],
70 [68],
76 [7],
7 [75],
75 in 13
comparison group [70],
68 [73],
64
63 [64],
trials the group sizes ranged from 25 to 49 [63],
77 [78],
78 [79],
79 [80],
80 [72],
72 [81],
66
81 [66],
[71],
65 [67],
67 [77],
71 [65],
[82],
and the remaining 19 trials allocated less than 25
82
women to each comparison group.
¥ Losses to follow up
Eight studies had no dropouts or losses to follow up
[83],
86 [82].
82 The propor83 [84],
85 [79],
79 [50],
69 [86],
84 [85],
50 [69],
tion of dropouts was less than 10% in six trials [63],
63
[71],
81 and in the remainder it varied
73 [81]
71 [78],
68 [73],
78 [68],
from 12% [64],
66 Only four trials clear64 [75]
75 to 37% [66].
ly reported some or all of their analysis on the basis of
70 [65],
72
64 [70],
65 [72].
intention to treat principles [64],
This section reviews the evidence comparing PFMT
with no treatment, placebo treatments, or any other
single intervention (e.g. electrical stimulation, surgery,
medication, etc). It also includes comparisons of different PFMT programs although PFMT with or without
biofeedback or intravaginal resistance is reviewed separately in this section. There are four published systema59 [60],
61
60 [61],
tic reviews pertinent to this section [59],
[62].
62 was
62 The Cochrane review by Hay-Smith et al [62]
the most up to date of these reviews, and included metaanalysis of trial data where appropriate. Therefore the
following summary of results and the recommendations
are based upon the rigorous review of trials of PFMT
identified by Hay-Smith et al. Readers are encouraged
to seek out the full report for details of the method,
results and further discussion.
¥ Post treatment follow-up
Nine of the 31 trials followed women up beyond the
66
post treatment evaluation [78],
71 [87],
72 [66],
87 [72],
78 [71],
[60],
83 [79].
60 [74],
74 [83],
79 Length of follow up ranged from
three months [71]
87 [60].
71 to five years [87],
60 Overall, data
from long-term follow up was sparse and difficult to
interpret. Often trial participants for whom treatment
had not been successful had gone on to receive alternative treatment. Therefore follow up data were usually
presented for all women participating in the study
rather than by original group allocation (e.g. [72]),
or
72
only one of the comparison groups was followed up
63
(e.g. [63]).
b) Quality of data
A brief summary of the quality of the trials included in
the systematic review by Hay-Smith et al is presented
below [62].
62 It is worth noting that there is one further
trial awaiting assessment for possible inclusion in the
Cochrane Review of PFMT [56]
56 that is relevant to this
section. Readers may wish to locate this most recent
trial to determine if the results are likely to alter the findings given below.
c) Results
¥ PFMT programs
There was considerable variation in the PFMT programs used in the included trials. The length of the trai85 and six months
ning period was between six weeks [85]
579
[63],
[76].
63 [83],
83
76 Some programs included hourly
contractions [78];
78 others used sets of contractions
repeated three times per day [63].
63 The number of
contractions per day ranged from 36 [63]
63 to 200 [71],
71
and the length of hold from three [71]
71 to 40 seconds
[83].
83 One program specifically included strength and
83 Individual teaching,
endurance training elements [83].
training and supervision was a feature of some pro71 [78],
grams [71],
78 [68]
68 whilst group teaching was used
73 and two trials used individual tea79 [73],
in others [79],
ching followed by group exercise [63],
63 [64].
64 In general,
many PFMT programs were poorly reported and other
advice/education given concurrently was rarely detailed.
Effective strength training relies on specificity (i.e. training reflects the functional activity of the muscle) and
overload (i.e. increasing resistance to, or duration of,
muscle contraction). To encourage specificity B¿ suggests that co-contraction of other related muscles (e.g.
glutei, hip adductors) should be minimized so that the
PFM are targeted and contraction of the PFM is not
masked by strong contractions of other muscle groups
[48]
48 . Research suggests that it is not possible to maximally contract the PFM without co-contraction of
Transversus Abdominus [63],
90 Contraction of
63 [90].
Transversus Abdominus can be observed as a tucking in
or bracing of the lower abdominal wall with no movement of the pelvis, and should be allowed in order to
facilitate maximum contractions. In addition, PFMT in
a variety of ÔfunctionalÕ positions such as sitting and
standing, rather than the traditional supine lying [63],
63
and the use of voluntary pelvic floor muscle contraction
prior to anticipated rises in intra-abdominal pressure
(e.g. with cough or sneeze) are more recent additions to
many PFMT programs [83],
83 [91],
91 [50].
50
In 1995 B¿ reviewed PFMT programs reported in the
literature and compared these with existing evidence on
the physiology of strength training in ÔnormalÕ voluntary muscle [48].
48 Few studies had used programs that
reflected current understanding of effective strength
training. Similarly, the current review found considerable variability in the content of PFMT programs,
which suggests there is still little knowledge, or consensus between practitioners, about what constitutes an
effective PFMT program. While the following paragraphs make recommendations for PFMT based on the
exercise science literature these should be viewed with
caution. The extrapolation is based on the equivalence
between the PFM of women with urinary incontinence
and ÔnormalÕ skeletal muscle. As there is a growing
body of research that documents nerve, muscle and
connective tissue changes in women with urinary
incontinence this equivalence is in doubt. However, as
some women (e.g. nulliparous women) experience urinary leakage without any obvious signs of this damage
it is possible that in these women the muscles are
ÔuntrainedÕ rather than damaged. Similar training principles are used for untrained, damaged and healthy
muscles, with training adapted to the needs and tolerance of each individual.
Effective overload strategies are likely to include close
to maximal voluntary pelvic floor muscle contraction,
increased length of contraction, increased number of
contractions and reduced rest periods. Strength training
theory suggests that near maximal contractions are the
most significant factor in increasing strength [92]
92 and
ideally contractions need to be sustained for 6-8
seconds to recruit an increasing number of motor units
93 There is a fixed recruitment
and fast twitch fibers [93].
pattern during voluntary contraction. Slow twitch (ST)
fibers are recruited first but with increasing resistance
more and more fast twitch fibers (FT) are recruited.
Fast twitch fibers possess low oxidative capacities and
fatigue easily. However, they are needed during rapid
movements and close to maximal contractions. All
types of muscle fibers will hypertrophy in response to
strength training but FT fibers have a greater potential
for hypertrophy than ST fibers. As the strongest stimulation for strength increase is the intensity of the
contraction (as close to maximum as possible), the
main objective in training is to recruit as many motor
units as possible, regardless whether they are ST or FT
fibers. To improve the potential for strength gains,
PFMT should be conducted over sufficient time that
both neural adaptation and hypertrophy can occur.
Thus, training periods of at least 20 weeks have been
recommended (American College of Sports Medicine
1992).
Success of PFMT will depend on ability to perform a
correct voluntary pelvic floor muscle contraction initially [88],
89 [45].
45 Therefore it seems appropriate
88 [89],
that all women should be taught how to perform a
voluntary pelvic floor muscle contraction by a person
with skills in the assessment and training of pelvic floor
muscles, and examined to check that a correct contraction is taking place, before PFMT is undertaken.
Prior to PFMT, a woman should be assessed by a
person with skills in the assessment and training
of pelvic floor muscles to ensure that a correct
voluntary pelvic floor muscle contraction is being
performed, and to determine if any facilitation
techniques or adaptations are required to the
recommended training program.
Extrapolation from research in other skeletal muscle
groups indicates that PFMT should include three sets of
eight to 12 slow velocity maximal contractions, three to
52 and training needs to be contifour times a week [52]
nued for 15 to 20 weeks (American College of Sports
Medicine 1992). However, indiscriminate use of this
580
Follow up data was reported by three trials, at three
months [71],
87 The
78 and five years [87].
71 nine months [78])
most complete and best quality data comes from the
follow up study undertaken by Lagro-Janssen and Van
Weel [87].
87 Data from 88 of the original sample of 110
women was reported. The number of continent women
(25%) was the same after five years but a significant
number of women reported their condition had worsened. Women with urge or mixed incontinence were less
likely to be satisfied with the outcome of treatment at
five years, although two thirds of all the women followed up remained satisfied with the outcome of treatment and did not want any further intervention. Nearly
half (43%) of the women who had received PFMT were
no longer training at all. For women with stress incontinence continued training was the only significant predictor of outcome at five years.
protocol may have adverse effects due to muscle
fatigue unless women are individually assessed to
determine the strength/weakness of their PFM. Depending on assessment findings of fatigability a modified
PFMT program may be needed initially, progressing to
meet the above recommendations. The need for modification relates to the dose response curve for training.
For example, a woman who is able to perform only four
near maximal contractions will begin her training at this
level. To recommend more than four near maximal
contractions at the outset may result in problems associated with over training. Alternatively, an insufficient
training dose inhibits progression and fails to maximize
training effect.
There is a marked lack of consistency in PFMT
programs used in clinical practice. On the basis
of extrapolation from exercise science literature,
PFMT programs should include three sets of
eight to 12 slow velocity maximal voluntary pelvic floor muscle contraction sustained for six to
eight seconds each, performed three to four times
a week and continued for at least 15 to 20 weeks.
The PFMT programs used in these seven trials varied
considerably and yet Hay-Smith et al [62]
62 reported a
consistent effect of PFMT. This raises a number of
questions about which element, or combinations of elements, of training are most effective. The recent trial by
Miller et al [50]
50 suggests for example that simply teaching a correct voluntary pelvic floor muscle contraction and the use of this contraction prior to an anticipated change in intra-abdominal pressure (i.e. ÒThe
KnackÓ) may be one element of an effective training
program. Anecdotally, contact with a health care professional with special training in continence management includes considerable advice/education on the
anatomy and physiology of the bladder and pelvic floor,
lifestyle advice, and information about good bladder
habits. These elements of intervention are rarely reported and their effect has not been investigated. Where
PFMT has been combined with other lifestyle and
behavioural interventions it is difficult to determine if
the effect of PFMT in comparison to Ôno treatmentÕ
reflects the effect of PFMT, the effect of the advice/education, or a combination of both. Other issues worthy of
consideration include the expertise of the person providing the PFMT, and the ÔintensityÕ of the PFMT program. There is some evidence that the latter is a factor
(see below Ð ÒStandard versus intensive PFMTÓ).
¥ PFMT versus no treatment
Seven trials, that randomised a total of 679 women,
have compared PFMT with no treatment [71],
71 [78],
78
[84],
84 [50],
50 [73]
73 or a control treatment (i.e. B¿ et al offered women use of the Continence Guard and
LagroÐJanssen et al provided advice on absorbent pro64 [68].
ducts) [64],
68 Three trials included women with
only urodynamic stress incontinence [64],
64 [78],
78 [84].
84
One trial included women with urodynamic diagnoses
71 The
of urodynamic stress or mixed incontinence [71].
three remaining trials included women with symptoms
50 [73].
73
68 [50],
of urine leakage [68],
The meta-analysis by Hay-Smith et al [62]
62 found that
PFMT was significantly better than no treatment for
self reported cure, self reported cure/improvement and
leakage episodes in 24 hours in women with stress
and/or mixed incontinence. A sensitivity analysis in
women with stress incontinence alone (symptom or
urodynamic) found that PFMT was significantly better
than no treatment for the rate of self reported
cure/improvement. The review also found that women
in PFMT groups also had consistently greater reductions in urine leakage on short pad test, and greater
improvements in measures of pelvic floor muscle acti62
vity [62].
It also suggested that self-reported
cure/improvement was a more common outcome of
PFMT than cure alone. Women in the PFMT groups
were 7.25 times more likely to be cured than women in
no treatment groups (RR 7.25, 95% CI 1.99, 26.49),
and this increased to 23.04 times for combined
cure/improvement (RR 23.04, 95% CI 7.56, 70.22).
There is level 1 evidence that PFMT is better than
no treatment for women with stress and/or mixed
incontinence.
¥ PFMT versus placebo treatments
Three trials, that randomised a total of 208 women,
compared PFMT with placebo treatments. The placebos
69 placebo medication [70],
70 and
were placebo PFMT [69],
85 The trials included
placebo electrical stimulation [85].
women with symptoms of stress incontinence only
69 urodynamic stress incontinence [85])
[69],
85 and women
581
up by B¿ & Talseth continued to be satisfied with the
outcome of PFMT and did not want any further treatment and 70% were continuing to train at least once a
week five years after supervised training ceased [60].
60
with detrusor overactivity with or without urodynamic
70 The meta-analysis by Haystress incontinence [70].
62 found a consistent effect, namely that
Smith et al [62]
PFMT was significantly better than placebo treatment
for self reported cure, self-reported cure/improvement
and leakage episodes in 24 hours. There were not sufficient data available to make sensitivity analysis by diagnostic group appropriate.
While not strictly a comparison of ÔstandardÕ and
ÔintensiveÕ PFMT a single trial comparing inpatient and
outpatient conservative management of urinary incontinence in women was found [94].
94 Management included
PFMT, bladder training, advice etc and the researchers
found symptoms of both groups significantly improved
with no clear benefit of inpatient over outpatient treatment. Ramsay et al [94]
94 concluded outpatient management was the more cost-effective option.
There is level 1 evidence that PFMT is better than
placebo treatments for women with stress, urge or
mixed incontinence.
¥ ÔStandardÕ versus ÔintensiveÕ PFMT programs
There is level 1 evidence to suggest that ÔintensiveÕ
PFMT is better than ÔstandardÕ training programs for women with stress incontinence, and
postnatal women with symptoms of urine leakage.
Six trials, that randomised 1080 women, compared
ÔstandardÕ versus ÔintensiveÕ PFMT programs. Two
trials compared a standard home based training program with the same program reinforced on audiotape in
women with urodynamic stress incontinence [67]
67 and
women with urodynamic stress incontinence, detrusor
overactivity and mixed incontinence [72].
72 Two trials, in
postnatal women with urine leakage, compared standard postnatal care with an individualized postnatal
PFMT program [7],
7 [66].
66 The two remaining trials, both
in women with urodynamic stress incontinence, compared home-based training with a program that included more contact with a physiotherapist [63],
63 [82].
82 One
of the six trials in this comparison did not report any
urinary outcomes [67]
67 and another did not present the
data by group allocation but by diagnosis [72].
72 Consequently neither trial contributed data to the meta-analysis. Hay-Smith et al [62]
62 found that ÔintensiveÕ training
was significantly better than ÔstandardÕ training for self
reported cure and self reported cure/improvement in
women with postnatal urine leakage and women with
stress incontinence. A sensitivity analysis in women
with urodynamic stress incontinence also found that
ÔintensiveÕ PFMT was significantly better than ÔstandardÕ training for self reported cure. The findings from
short pad tests and measures of pelvic floor muscle activity did not consistently favour one group over the
other. For both these outcomes B¿ et al [63]
63 reported
significantly greater improvement in the ÔintensiveÕ therapy group versus the ÔstandardÕ treatment group, whereas Wong et al [82]
66
82 and Wilson and Herbison [66]
reported improvements in both standard and intensive
groups with no significant differences between the
groups.
¥ PFMT versus electrical stimulation (ES)
Hay-Smith et al combined data from eight trials, in 295
women with urodynamic stress incontinence that com62 Interferenpared PFMT and electrical stimulation [62].
tial therapy was used in three trials [78],
78 [95],
95 [74],
74 four
trials used some other form of pulsed alternating current [64],
96 and in one trial the type of
83 [86],
86 [96],
64 [83],
stimulation was not specified [85].
85
However the clinical heterogeneity (i.e. considerable
variation in the types of electrical stimulation used, and
the stimulation protocols) made it difficult to combine
the findings of these studies in a meaningful way. Hay62 did not find any significant differences
Smith et al [62]
between PFMT and electrical stimulation groups for
self reported cure although this comparison was extremely close to favouring PFMT. Similarly rates of self
reported cure/improvement was not significantly different between the groups, However when the data from
the two trials [64],
64 [83]
83 that compared PFMT with long
term intravaginal stimulation in women with stress
incontinence were combined this was statistically in
favour of PFMT for self reported cure/improvement.
The findings from a variety of pad tests were not
consistent.
Three trials reported follow up beyond post treatment
78 approximately two
evaluation, at nine months [78],
years [74]
74 and four years [83].
83 The most complete and
best quality data comes from the study by Hahn et al
83 who followed up 19 of the 20 women who partici[83]
pated in the original trial. Five had incontinence surgery, four were further improved, eight were unchanged
and two had recurrent symptoms. Three women were
not doing any PFMT, six were training Ònow and thenÓ,
and five were doing PFMT ÒregularlyÓ.
Follow up beyond post treatment assessment was reported by three trials, at six months [72],
72 15 to 35 months
66 and five years [63].
[66]
63 There were difficulties interpreting the data from the two former trials, and the latter trial followed up only the women from the ÔintensiveÕ training group. Fourteen of the 23 women followed
582
Only the trial by Henalla et al [84]
84 included follow up
beyond the end of treatment. At nine months three of 17
women in the PFMT had recurrent leakage whereas all
three women who had initially improved with topical
oestrogens had recurrent symptoms when oestrogen
therapy was discontinued.
Due to the variation in electrical stimulation types
and protocols tested in the existing trials it was
difficult to combine the findings in a meaningful
way. At present there is insufficient evidence of
the effect of PFMT versus electrical stimulation in
women with stress incontinence.
¥ PFMT versus surgery
¥ PFMT versus weighted vaginal cones
Two trials, in 94 women with urodynamic stress incontinence, compared surgery with PFMT. The surgical
procedure varied in one trial depending on the basis of
voiding cystourethrogram [79]
79 and in the other trial all
women randomised to surgery had an open Burch col98 Unfortunately the trial by Tapp et al
posuspension [98].
98
[98] has only been reported in two abstracts. As there
were inconsistencies in the data reporting between the
abstracts the data were excluded from consideration.
On the basis of one trial, in women with urodynamic
stress incontinence, many more women in the surgery
group reported cure post treatment, although there was
no significant difference in the rate of self reported
cure/improvement between the groups. Women in the
surgery group also had significantly fewer leakage episodes in 24 hours post treatment.
PFMT and vaginal cones were compared in seven trials
that randomised a total of 539 women. Five trials inclu64
ded women with urodynamic stress incontinence [64],
[65],
81 one trial included women with
65 [77],
77 [97],
97 [81],
80 and one trial
symptoms of stress incontinence only [80]
was in postnatal women with symptoms of urine leakage [66].
62 found that women with
66 Hay-Smith et al [62]
urodynamic stress incontinence had significantly fewer
leakage episodes in 24 hours after PFMT than cones.
All other outcomes were less clear-cut; with some trials
favouring neither treatment while others favoured
PFMT or cones.
One trial [66]
66 included long-term follow up, at 15 to 32
months post treatment. It was difficult to interpret the
findings as data from three of the comparison groups
was combined (three groups received treatment from a
physiotherapist but not all three groups received training with vaginal cones) and compared with the standard postnatal care group.
For comparisons of PFMT with medication or
surgery only a single trial was found for each
comparison and/or the trial reporting was very
poor. The following statements should be viewed
only as hypotheses that require further testing. In
women with stress and mixed incontinence there
may be no difference between PFMT and phenylpropanolamine, but in women with detrusor overactivity with or without urodynamic stress incontinence PFMT may be better than oxybutynin
chloride. In women with urodynamic stress incontinence PFMT may be better than topical oestrogens, but surgery may be better than PFMT.
There is a lack of consistency in the findings from
trials comparing PFMT and weighted vaginal
cones. At present there is insufficient evidence of
the effect of PFMT versus vaginal cones in women
with stress incontinence or postnatal women with
symptoms of urine leakage
¥ PFMT versus bladder retraining (behavioural therapy)
(Please refer to the section on bladder retraining, Section IV)
¥ PFMT versus medication
PFMT has been compared with topical oestrogens [78],
78
84 with anticholinergic (oxybutynin chloride) [70],
[84]
70
and with alpha adrenergic (phenylpropanolamine) [76].
76
Both oestrogen trials, in women with urodynamic stress
incontinence, found that the PFMT group was more
likely to be cured or improved on short pad test. PFMT
was better than oxybutynin chloride for self-reported
cure/improvement and the number of leakage episodes
in 24 hours for women with detrusor overactivity with
or without urodynamic stress incontinence, although
there was no significant difference in the rate of self
reported cure between the groups. The findings from
the trial comparing PFMT with phenylpropanolamine
in women with stress or mixed incontinence did not
clearly favour one group over the other.
d) Summary
There is a lack of consistency in PFMT programs that
implies an underlying lack of understanding of the physiological principles of rehabilitating (pelvic floor)
muscle, or differences in muscle training philosophies.
However, there is Level 1A evidence to suggest that in
women with stress or mixed incontinence PFMT is better than no treatment, and placebo treatments. There is
also Level 1 evidence that ÔintensiveÕ PFMT programs
are more effective than ÔstandardÕ training programs.
There is conflicting evidence and/or difficulties in combining the findings of trials comparing the effects of
PFMT with electrical stimulation, vaginal cones, medications and surgery. Thus, the effectiveness of PFMT
versus electrical stimulation, vaginal cones, medication
and surgery is unclear. The long-term outcome of
PFMT is also unclear, although on the basis of limited
583
data women may continue to be satisfied with the outcome of training for up to five years.
ning (Figure 3) but may also give simultaneous BF. Presumably combination therapies have become popular
as they are thought to be more effective than PFMT
alone.
e) Recommendations
PFMT should be offered as therapy to women with
stress and mixed incontinence (Grade of recommendation Ð A). For women with mixed and urge incontinence it may be appropriate to offer PFMT in combination
with bladder training.
On the basis of extrapolation from the exercise science
literature B¿ suggests that PFMT programs include
three sets of eight to 12 slow velocity maximal voluntary pelvic floor muscle contractions, sustained for six
to eight seconds each, performed three to four times a
week, and continued for 15 to 20 weeks [48].
48
The addition of voluntary pelvic floor muscle contraction in a variety of functional positions and prior to
anticipated changes in intra-abdominal pressure is also
recommended. Prior to PFMT a person with skills in
the assessment and training of pelvic floor muscles
should assess each woman to ensure that a correct
voluntary pelvic floor muscle contraction is being performed and to determine what facilitation techniques or
adaptations, if any, are required to the recommended
training program to ensure an appropriate training
intensity. (Grade of recommendation - C).
Figure 1 : Surface EMG electrodes on vaginal probe
More high quality RCTs, with long term follow up, are
needed to investigate the effectiveness of PFMT relative to other physical therapies, conservative management strategies, pharmaceuticals and surgery. Further
comparisons of different types of PFMT to determine
which components, or combinations of components,
are most effective are also required.
3. BIOFEEDBACK AND/OR INTRAVAGINAL
RESISTANCE
Figure 2 : Vaginal biofeedback (pelvic floor muscle
contractility reflected on a lighted scale on the screen)
a) Background
Biofeedback (BF) is commonly used in conjunction
with PFMT to assist with training. Intravaginal resistance devices (IVRD) are less common but have also
been used to enhance the training process. BF involves
the use of monitoring instruments to detect and amplify the various internal physiologic events or conditions
of which the person is usually unaware [99].
99 BF may
involve vaginal or anal probes using pressure or electromyographic sensors with information produced in
visual and/or auditory form (Figures 1, 2) Information
about how the PFM are functioning is presented to the
patient to facilitate awareness and co-ordination, and to
provide motivation during strength training. Intravaginal resistance devices (e.g. balloon catheters, perineometers etc) provide resistance to enhance strength trai-
Figure 3 : Perineometer
584
[103]
103 awaiting assessment for inclusion in the review
by Hay-Smith et al. Readers may wish to locate this
paper in order to judge for themselves if the results
would affect the findings presented below.
For the purposes of this review all forms of BF were
included, e.g. pressure perineometers with visual or
auditory display, electromyography from vaginal
probes, etc. To be classified as a trial including BF,
repeated use of the BF device was required. This excluded trials where the sole purpose of BF was to assist in
the teaching of correct voluntary pelvic floor muscle
contraction and was not used thereafter (e.g. [70]).
70
IVRDs that used a pressure filled vaginal probe (e.g.
water or fluid filled) were included. While weighted
vaginal cones might be considered as a resistance-training device they have been reviewed separately as their
proposed mode of action differs from that of pressure
devices (see Weighted Vaginal Cones, Section III.5)
(Figure 4).
¥ Random allocation concealment
Of the 11 trials contributing to this section the random
allocation concealment was adequate in two [102],
102
91 and in the remainder it was either unclear if allo[91],
cation was adequately concealed or the authors stated
simply that allocation was at ÒrandomÓ [71],
104
71 [104],
110
[105],
80 [107],
105 [106],
106 [80],
107 [108],
108 [109],
109 [110].
¥ Masking of participants and assessors
Two trials clearly stated that outcome assessors were
masked to group allocation [102],
71 and in the
102 [71]
remainder this was not reported.
¥ Sample size and power calculation
None of the 11 trials reported the power calculation
used to estimate the size of the study population. None
of the trials was large. Only two trials randomised more
than 25 women to each comparison group [71],
71 [80]
80
and in both cases the comparison groups number less
than 50. The remaining trials all included less than 25
women per comparison group.
¥ Losses to follow up
Four trials had no dropouts or losses to follow up [102],
102
[104]
,
[105],
[106].
The
proportion
of
dropouts
was
105
106
104
109 and in the
less than 10% in two trials [71],
71 [109]
remainder it varied from 14% [107]
107 to 33% [80]. None
of the studies clearly stated that the analysis was on the
basis of intention to treat.
Figure 4 : Vaginal Cones
¥ Post treatment follow-up
Two trials followed women up beyond the post treat71 and two to three
ment assessment, at three months [71])
91
years [91].
This section reviews the trials comparing PFMT alone
with BF assisted PFMT, or PFMT resisted by an intravaginal pressure device. Five systematic reviews that
included trials comparing PFMT with or without BF
59 [100],
101 [102],
102
100 [101],
and IVRD were identified [59],
62 The Cochrane review by Hay-Smith et al was the
[62].
most up to date of these reviews, and included metaanalysis of trial data where appropriate. Therefore the
following summary of results and the recommendations
are based upon the rigorous review of trials of PFMT
(with or without BF or IVRD) identified by Hay-Smith
62 Readers are encouraged to seek out the full
et al [62].
report for details of the method, results and discussion.
c) Results
¥ BF protocols
There is some variation in the types of BF used. Five
trials used BF from a vaginal probe with EMG elec71 [91],
91 [108],
108 [110].
102 [71],
110 The other five
trodes [102],
trials used a vaginal probe sensitive to pressure changes
104 [106],
106 [80],
80 [107],
107
109 Visual feedback was
[104],
[109].
provided in all the trials, and two devices provided
102 , [106].
106 Four trials used cliauditory feedback too [102]
71
102
110 and three recom91
nic only BF [102], [71], [91], [110],
107 Two trials
80 [107].
104
mended daily BF at home [104], [80],
108
106 [108],
used a mix of both clinic and home BF [106],
and the remaining trial compared home and clinic BF
109 The number of treatments with BF and the ove[109].
rall length of treatment varied considerably, and in one
b) Quality of Data
A brief summary of the quality of the trials included in
62 is prethe systematic review by Hay-Smith et al [62]
sented below. It is worth noting that there is one further
trial, published as an abstract of a study in progress
585
trial the PFMT group had fewer clinic visits than the
biofeedback group [91].
91
effect of IVRD [105],
105 [109]
109 included any data that were
able to contribute to the meta-analysis by Hay-Smith et
al [62].
62 Overall, there were not any significant differences between the IVRD and PFMT groups.
¥ BF assisted PFMT versus PFMT alone
Ten trials, which randomised a total of 389 women with
urodynamic stress (four trials), stress (four trials) or
urodynamic stress incontinence with or without detrusor overactivity (two trials), compared BF assisted
PFMT with PFMT alone. The meta-analysis by HaySmith et al [62]
62 found no statistically significant differences between the groups for rates of self reported cure
or cure/improvement, or the number of leakage episodes in 24 hours. A similar trend was seen in the pad
test data and measures of pelvic floor muscle activity.
There were insufficient data in any of the comparisons
to make sensitivity analysis on the basis of diagnostic
group appropriate. However the data that suggested no
difference between the groups for self reported
cure/improvement all came from trials in women with
urodynamic stress incontinence alone.
d) Summary
There is some variation in BF protocols that may reflect
availability of BF equipment and the ongoing technical
developments in this area. There is Level 1 evidence to
suggest that BF assisted PFMT is no more effective
than PFMT alone in women with urodynamic stress or
mixed incontinence. There is insufficient evidence to
make a judgment about the effectiveness of IVRD in
women with stress incontinence.
e) Recommendations
There is no apparent difference in the effectiveness of
PFMT with or without BF (Grade of recommendation A) although clinicians may find occasions when BF is
a useful adjunct to treatment for the purposes of teaching, motivation, compliance, etc.
Data from one trial [102]
102 suggested that the BF group
improved more quickly than the PFMT only group (at
six weeks), although there were no significant differences either at six weeks or post treatment (12 weeks)
but this has not been investigated or confirmed by any
other BF study to date. A group that are, anecdotally,
reported to benefit from BF are those women who are
not able to voluntarily contract their PFM initially but
this hypothesis has not been investigated to date.
Further large, high quality RCTs are required to investigate the effectiveness of BF assisted PFMT. Two areas
requiring attention are women who are not able to
voluntarily contract their PFM or have a very poor quality (intensity) of contraction at initial assessment, and
the rate of improvement in BF assisted training versus
PFMT alone. The effect of intravaginal pressure
devices to assist PFMT has not been adequately investigated to date.
Only two trials included follow up post treatment, and
the most complete and best quality long-term follow up
data was provided by Glavind et al [91].
91 The BF group,
who had more clinic visits than the women receiving
PFMT alone, were more likely to report continued cure
or improvement at two to three years, and were also
more likely to be doing regular PFMT.
4. ELECTRICAL STIMULATION
a) Background
The literature concerning electrical stimulation in the
management of urinary incontinence is very difficult to
interpret. Perhaps the primary cause is the lack of a
well-substantiated biological rationale underpinning
the use of electrical stimulation. However, the theoretical basis of stimulation interventions is emerging with
increasing understanding of the neuro-anatomy and
physiology of the central and peripheral nervous systems. It is also becoming clear that the mechanisms of
action may vary depending on the cause(s) of incontinence and the structure(s) being targeted by electrical
stimulation, e.g. pelvic floor muscle or detrusor muscle,
peripheral or central nervous system. In general, the
aim of electrical stimulation for women with stress
incontinence appears to be to improve the function of
the pelvic floor muscles, while for women with urge
incontinence the objective seems to be to inhibit detrusor overactivity. Overall, studies poorly report the biological rationale underpinning the application of electrical stimulation being tested.
There is level 1 evidence that BF assisted PFMT is
no more effective than PFMT alone for women
with stress and mixed incontinence. At present
there is insufficient evidence to determine the
effect of IVRD in women with stress incontinence.
¥ PFMT with IVRD versus PFMT alone
Four small trials, in women with stress incontinence,
were included in this comparison. Two trials clearly sta105 [109].
109
ted that an IVRD was used with PFMT [105],
The two remaining trials used a pressure device to
107 [106]
106 and this
ÔexerciseÕ the pelvic floor muscles [107],
device also provided BF. As the primary intent of the
intravaginal device in the latter two trials was not clear
(i.e. resistance versus biofeedback) these two trials
were included in both the BF and IVRD sections. Neither of the two trials that were clearly investigating the
586
Electrical stimulation is provided by clinic based mains
powered machines (i.e. those that need to be plugged
into a wall socket) but also more recently portable battery powered stimulators (Figure 5). Electrical stimulation also offers a seemingly infinite combination of current types, waveforms, frequencies, intensities, electrode placements etc. Without a clear biological rationale
it is difficult to make reasoned choices of electrical stimulation parameters. Additional confusion is created
by the relatively rapid developments in the area of electrical stimulation and a wide variety of stimulation
devices and protocols have been used even for the same
condition. For example, in the last 15 years or so
women with stress incontinence have been treated
using anything from a single episode of maximal stimulation under general anaesthetic for 20 minutes with
vaginal and buttock electrodes [111],
111 to 10 sessions of
Interferential therapy at 10 to 40 Hz with perineal body
and symphysis pubis electrodes [74],
74 to six months of
low intensity stimulation at 10 Hz using a vaginal electrode [112].
112
This section reviews the evidence comparing electrical
stimulation (ES) with no treatment, placebo ES and
comparisons of different ES protocols. It also includes
trials comparing ES with any other single intervention
(e.g. surgery, medication etc) except (a) ES versus
PFMT, which is included in the section on PFMT, and
(b) ES versus weighted vaginal cones, which is included in the section on vaginal cones. Three systematic
reviews [61],
61 [56],
56 [62]
62 have been published that include trials relevant to this section. However none of the
reviews appeared to include a complete record of all the
available trials. The following qualitative summary of
the evidence regarding electrical stimulation is based
on the trials included in both of the previous systematic
reviews with addition of trials located through additional searching (see Appendix 1). To be included in this
section a trial needed to (a) be a RCT, (b) include
women with urinary incontinence, and (c) investigate
the effect of electrical stimulation versus no treatment,
placebo treatment, any other single treatment, or compare different electrical stimulation protocols. Abstracts
reporting trials in progress were excluded.
b) Quality of data
One of the trials located [113]
113 was excluded from the
analysis as it was a preliminary report of a trial in progress. Readers should also note that the trials by Yamanishi et al [114]
114 included men and women with urinary
incontinence. It is possible that the effects of stimulation might be different between sexes (due to difference in electrode placement for example) so these studies
have not contributed to the analysis where they do not
differentiate the effects of treatment in women versus
men.
¥ Random allocation concealment
Figure 5 : Electrostimulator with vaginal probe
Of the 20 trials contributing to this section random allo56 [64],
64
cation concealment was adequate in three [56],
112 and in the remainder it was either unclear if allo[112],
cation was adequately concealed or the authors simply
stated that allocation was at ÒrandomÓ.
Finally the nomenclature used to describe electrical stimulation has been inconsistent. Stimulation has sometimes been described on the basis of the type of current
being used (e.g. Faradic stimulation, Interferential therapy), but is also described on the basis of the structures
being targeted (e.g. neuromuscular electrical stimulation), the current intensity (e.g. low-intensity stimulation, or maximal stimulation), and the proposed mechanism of action (e.g. neuromodulation). In the absence
of agreement of how best to classify electrical stimulation the authors of this chapter have made no attempt to
do so. The authors were also reluctant to use any existing system to group the electrical stimulation protocols
in the trials as many were poorly described and could
therefore be erroneously classified.
¥ Masking of participants and assessors
Masking of assessors was clearly stated in nine of the
111
117 [118],
116 [117],
118 [111],
115 [116],
20 trials [56],
64 [115],
56 [64],
[114],
119 Two trials stated that outcome assessors
114 [119].
78 and in the remainder this
were not masked [74]
74 , [78],
was not reported.
¥ Sample size and power calculation
In five studies the size of the study population was
116 [117],
56 [64],
based on a power calculation [56],
64 [116],
117
118 Two trials randomised more than 50 women to
[118].
each comparison group [120],
[111].
111 In six trials the
120
64
78
116
group sizes ranged from 25 to 49 [64],
[78],
[116],
98 , [119],
[117],
119 and the remaining 12 trials allocated
117 [98]
less than 25 women to each comparison group.
587
¥ Losses to follow up
tocols. Both the trials by Hofbauer et al [85]
85 and Knight
112 also asked women to add a voluntary PFM
et al [112]
contraction to the stimulated contraction, although in
the latter trial this was only for the maximal intensity
group.
Four trials had no dropouts or losses to follow up [118],
118
85 [74]
121 The proportion of dropouts was less
[85],
74 , [121].
78 [86],
than 10% in four trials [115],
86 [114],
115 [78],
114 and in
111
56 [64],
the remainder it varied from 12% [56],
64 [111],
122 [119])
[122],
123
119 to 21% [123].
Current was most commonly delivered via a single
120 [112],
112 [116],
117 [121].
vaginal electrode [64],
121
64 [120],
116 [117],
One trial used both vaginal and buttock electrodes
111
[111].
In two trials external electrodes were used, per74 perineal and butineal body and symphysis pubis [74],
115
tock [115], and in two studies the electrode placement
78
was not clearly described [78],
[85].
85
¥ Post treatment follow-up
Nine of the 20 trials followed women up beyond the
115 [78],
78 [85],
112 [74]
post treatment evaluation [115],
74
85 [112],
122 [111],
111 [114],
119 The length of follow-up ran114 [119].
,[122],
78 [85],
111 to six months [115],
85
ged from 6 weeks [111]
115 [78],
119 only followed up
114 [119]
112
[112].
Yamanishi et al [114],
those participants who had improved with treatment,
monthly for several months.
The length and number of treatments was also highly
variable. The longest treatment periods included daily
112 Medium
64 [112].
treatment at home for six months [64],
length treatment periods were based on twice-daily
116
treatment at home for eight [120]
120 to 12 weeks [116],
117 The shortest treatment periods were all for clinic[117].
based stimulation, ranging from 10 [78],
74 to 16
78 [74],
85
[112],
112 and 18 sessions in total [85].
c) Results
¥ ES protocols
Some ES protocols were poorly reported, lacking detail
of stimulation parameters, devices and methods of delivery. However, on the basis of the details that have been
reported it appeared that there was considerable variation in ES protocols with no consistent pattern emerging.
2. ES
PROTOCOLS FOR WOMEN WITH URGENCY, URGE
INCONTINENCE, DETRUSOR OVERACTIVITY
Although it appeared all the ES trials in this section
used alternating current only three trials specifically
120 biphasic pulsed
stated this, biphasic [56];
56 bipolar [120];
current [86].
These
same
three
trials
were the only ones
86
to detail the pulse shape, rectangular [56];
56 square [120];
120
asymetric [86].
86
1. ES PROTOCOLS FOR WOMEN WITH STRESS INCONTINENCE
Few trials clearly stated whether direct or alternating
currents were being used. Two earlier trials [121],
121 [98],
98
used faradic current (low frequency interrupted direct
current) but it is assumed that most if not all of the
remaining trials used alternating currents. In those trials
using alternating current only one trial described the
pulse shape Ð a bipolar square wave [120].
120
Four trials gave details of the frequencies used and
these ranged from 10 Hz [118]
120 , a com118 to 20 Hz [120]
bination of 12.5 & 50 Hz [86]
56
86 , and 10 to 40 Hz [56].
Pulse durations were reported in four trials, and these
56
120 , 200 microseconds [56],
were 0.1 microseconds [120]
86 Two trials used a
[118],
118 and 300 microseconds [86].
120 [86].
86
duty cycle ratio of 1:2 [120],
The most commonly used descriptors were frequency
and pulse duration. Four trials used a single frequency,
ranging from 20 Hz [120]
120 to 50 Hz [64],
64 [116]
116 . Two
trials included stimulation at both 10 Hz and 35 Hz
[115],
[112]
115
112 although the protocols were different.
Other protocols included stimulation at 12.5 Hz and 50
Hz [117],
0 to 100 Hz [78],
111
117 10-50 Hz [111]),
78 and finally a 30 minute treatment including 10 minutes at 1 Hz,
10 minutes 10 - 40Hz and 10 minutes at 40 Hz [74]
74 .
Pulse durations ranged from 0.08 milliseconds [115]
115 up
to 100 milliseconds [120].
120 Six trials also detailed the
duty cycle used during stimulation. The ratios ranged
from 1:3 [64],
115 , [112])
64 and 1:2 [120]
112
116 to 1:1 [115]
120 , [116],
and one trial alternated between a ratio of 1:1 and 1:2
[117].
117
Intensity of stimulation progressed from five to 25 mA
in the trial by Smith [86].
86 Three trials used the maxi118 [120]
120 , and one
mum tolerable intensity [56],
56 [118],
study increased intensity up to the pain threshold [123].
123
Current was most commonly delivered by a vaginal
electrode [56],
[120],
[86]
86 or vaginal and anal elec56
120
trodes [123],
123 [122]
122 although one trial used external surface electrode placements with two electrodes over S23 sacral foramina or two electrodes just above the symphysis pubis [118].
118
The length and number of treatments was also highly
variable. The longest treatment period was four months
of daily stimulation [86].
86 Medium length treatment periods were based on twice daily stimulation for eight
[120]
120 , nine [124]
124 or 12 weeks [123].
123 The shortest treatment period consisted of a single episode of stimulation
after the voiding phase of cystometry before filling was
Four trials asked women to use the maximum tolerable
intensity of stimulation [64]
120 , [74]
117 and
64 , [120]
74 , [117]
one trial increased output until there was a noticeable
muscle contraction [85].
112
85 The trial by Knight et al [112]
compared Òlow intensityÓ and Òmaximal intensityÓ pro-
588
main outcome measures were change in the Detrusor
Overactivity Index (DAI) and the Incontinence Impact
Questionnaire (IIQ). Neither the no treatment or combination therapy groups showed any significant change
pre to post treatment. There were significant improvements in the electrical stimulation alone and PFMT
alone groups for the DAI and a positive (but not significant) trend towards improvement in the IIQ. When the
data from women with ÔprovenÕ detrusor overactivity at
baseline (DAI > 0.5) were analysed separately the most
significant improvements in the DAI were seen in the
electrical stimulation group. Overall it appeared that
electrical stimulation was better than no treatment.
118 One trial compared clinic based stimurepeated [118].
lation once a week versus twice a week for five and up
to 10 weeks [122].
122
There is a marked lack of consistency in the electrical stimulation protocols used in clinical practice to treat women with stress, urge and mixed
incontinence. This seems likely to continue until
the infinite variation of stimulation parameters
available to researchers and clinicians is narrowed by further investigation into the biological
rationale underpinning electrical stimulation.
¥ ES versus no treatment or control treatment
There are only single trials of good quality investigating the effect of electrical stimulation versus
no treatment (or control treatment) in women
with urodynamic stress incontinence or women
with detrusor overactivity. Consequently there is
insufficient evidence to judge whether electrical
stimulation is better than no treatment for women
with urodynamic stress incontinence or detrusor
overactivity.
1. WOMEN WITH STRESS INCONTINENCE
A single, small trial has compared ES with no treatment
78 Eight of the 25
in women with stress incontinence [78].
women receiving ES were ÔobjectivelyÕ cured or improved (negative pad test or more than 50% reduction in
pad test) at three months, versus none of the 25 women
in the no treatment group. One trial has compared ES
with control intervention (women were offered use of
the Continence Guard (Coloplast AS, used infrequently
by 14 out of 30 controls) in women with stress incontinence [64].
64 B¿ et al found that ES was better than
control intervention for change in leakage episodes
over three days, using Social Activity Index and Leakage Index. However, only one of these measures (change in leakage episodes over three days) remained significant (p=0.047) with intention to treat analysis. PFM
activity was significantly improved in the ES group
after treatment, but the change in activity was not significant when compared with controls. Two of 30 controls
were cured (< 2 g leakage) on pad test with standardized bladder volume on pad test) compared to 7/25 in
the ES group. One of 30 women in the control group
reported the condition was ÒunproblematicÓ after treatment versus 3/25 in the ES group, but 28/30 and 19/25
wanted further treatment respectively.
2. WOMEN WITH URGENCY/FREQUENCY,
NENCE, RETENTION/VOIDING DIFFICULTY
¥ ES versus placebo ES
In three of the 11 trials the placebo stimulation devices
provided a limited output that the trialists considered
115 [85],
117 In the
85 [117].
would have no treatment effect [115],
other eight trials the placebo device appeared as though
it was working but in fact there was no electrical output
[123],
[111],
114 [119].
74 , [116],
123 [118],
118 [120],
120 [74]
116
119
111 [114],
Seven of the 11 trials specifically reported that some
attempt was made to remove the participantsÕ expectations of the physical sensations that might accompany
stimulation in an effort to mask participants to their
120
118 [120],
allocation to active or placebo stimulation [118],
114 [119].
[74],
74 [116],
119 In one trial the stimula116 [117],
117 [114],
111
tion was delivered under general anaesthesia [111].
1. WOMEN WITH STRESS INCONTINENCE
URGE INCONTI-
Four trials compared ES with placebo ES in women
with urodynamic stress incontinence [85],
85 [74],
74 [116],
116
117
[117]. One trial compared ES with placebo ES in men
and women with urodynamic stress incontinence [114].
114
115 compared ES/PFMT
One further trial compared [115]
versus placebo ES/PFMT in women with urodynamic
stress incontinence and for the purposes of analysis this
trial was considered to be a comparison of ES with placebo ES. Hofbauer et al [85]
85 provided minimal detail of
participants, methods and stimulation parameters. Laycock & Jerwood [74]
74 used clinic based, short-term (10
treatments) maximal stimulation with an Interferential
current applied with external surface electrodes. Four
trials were based on daily home stimulation for four
116 [117].
[114],
115 or 12 weeks, [116],
117
114 six [115]
Rosier et al (1997) investigated the effect of sacral neuromodulation for urgency/frequency an/or urge inconti125
nence and/or retention/voiding difficulties [125].
Unfortunately the abstract only reports the quality of
life data from 35 people (all women) who took part in a
larger multicentre study, and the data were not presented by comparison group.
In a four arm RCT in women with detrusor overactivi56 investigated the effect of no
ty Berghmans et al [56]
treatment, lower urinary tract exercises alone (reclassified as PFMT for the purposes of this review), electrical stimulation alone, and electrical stimulation in combination with lower urinary tract exercises. The two
589
The two most comparable trials in terms of stimulation
parameters reported contrasting findings. Sand et al
117 found that the ES group has significantly greater
[117]
changes in the number of leakage episodes in 24 hours,
number of pads used, amount of leakage on pad test,
and PFM activity (perineometry) than the placebo stimulation group. In addition the ES group had significantly improved subjective measures (e.g. visual analogue measure of severity) than the placebo group. Neither group demonstrated significant change in the quality of life measure (SF 36). In contrast Luber & Wolde116 did not find any statistically significant
Tsadik [116],
differences between ES and placebo ES groups for rates
of self reported cure or improvement, objective cure
(negative stress test during urodynamics), number of
incontinence episodes in 24 hours, or valsalva leak
point pressure.
118 used a single stimulation episode
Bower et al [118]
given after the voiding phase of cystometry and before
bladder filling was repeated. The results were reported
separately for women with detrusor overactivity and
those with sensory urgency. For women with detrusor
overactivity both stimulation groups (10 Hz, sacral
electrodes and 150 Hz, symphysis pubis electrodes)
showed significant improvements in urodynamic measures when compared with the placebo stimulation
group (i.e. reduction in maximum detrusor pressure,
increase in first desire to void, proportion of women
with a stable bladder). However there were no significant differences between stimulation and placebo
groups for change in maximum cystometric capacity or
detrusor pressure at first desire to void. Fewer measures
were reported for women with sensory urgency. The
only significant findings were a significant increase in
first desire to void in the 150 Hz group, and a significant increase in the maximum cystometric capacity in
the placebo ES group.
The other trials generally favoured ES over placebo ES.
114 reported significant improvement
Yamanishi et al [114]
in a range of outcomes in the ES group but not the placebo ES group (i.e. number of leakage episodes, number of pad changes, disturbance in activities of daily
living, self report of improvement, pad test). Laycock
& Jerwood [74]
74 generally found significantly greater
improvements in the ES group (pad test, PFM activity,
self reported severity) although the decrease in incontinence episodes was not significantly different between
the groups post treatment. Blowman et al [115]
115 found a
significant decrease in the number of leakage episodes
in the ES group only. Hofbauer et al [85]
85 reported that
3/11 women in the ES group were cured/improved (not
defined) versus 0/11 in the placebo ES group.
Yamanishi et al [119]
119 investigated maximum intensity
stimulation delivered daily for four weeks in men and
women with detrusor overactivity. There was significantly more improvement in a number of outcomes in
the ES group compared with the placebo ES group post
treatment (i.e. nocturia, number of leakage episodes,
number of pad changes, quality of life score, urodynamic evidence of improvement in detrusor overactivity,
self report of cure or improvement). For a single outcome, self report of cure/improvement, subgroup analysis
on the basis of sex was reported. Women in the active
ES group were much more likely to report cure/improvement than women in the placebo ES group.
One further trial [120]
120 that compared ES with placebo
ES in a group of women with urodynamic stress incontinence, detrusor overactivity or both, conducted a subgroup analysis on the basis of diagnosis and did not find
any changes in urodynamic measures for women with
USI in either ES or placebo ES groups.
120 that compared ES with placebo
One further trial [120]
ES in a group of women with urodynamic stress incontinence, detrusor overactivity or both, conducted a subgroup analysis on the basis of diagnosis and found that
women with pretreatment detrusor overactivity who
received active stimulation were significantly less likely to have urodynamic evidence of detrusor overactivity post treatment.
2. WOMEN WITH URGENCY, SENSORY URGENCY, DETRUSOR
OVERACTIVITY, URGE INCONTINENCE
Three trials were identified. Due to the considerable
difference in stimulation parameters and sample populations it does not seem appropriate to try and combine
the findings of these trials in any way.
3. WOMEN WITH STRESS, URGE OR MIXED INCONTINENCE
ES and placebo stimulation were compared in two trials
111 or urodynathat included women with symptoms [111]
120 diagnoses of stress, urge or mixed incontimic [120]
nence. Neither trial found any significant differences
between the stimulation and placebo stimulation groups
post treatment for a range of outcomes including frequency, number of leakage episodes, self report of cure
or improvement and quality of life. Brubaker et al [120]
120
did include a subgroup analysis by diagnosis and these
findings have been reported previously.
123 randomized 28 postmenopausal detruAbel et al [123]
sor overactivity incontinent women to either active stimulation (maximal anal and vaginal stimulation for 20
minutes once a week for 12 weeks) or placebo stimulation (no current). The results showed a significant
improvement in subjective parameters (VAS) but not in
objective measurements (24 hour pad test and incontinence episodes per day).
590
It is important to note that Berghmans et al [56]
56 theorise that the combination of stimulation/PFMT used in
their trial may be counterproductive because the former
is targeted at the supraspinal reflexes while the latter
may work on central inhibition.
Due to the variation in stimulation protocols it is
difficult to interpret the findings of trials comparing electrical stimulation with placebo stimulation. For women with urodynamic stress incontinence the findings of two good quality trials using
similar stimulation protocols are contradictory.
For women with detrusor overactivity there is a
trend in favour of active stimulation over placebo
stimulation.
For comparisons of electrical stimulation with
PFMT versus PFMT alone the reporting was very
poor in three of the four trials in women with
stress incontinence, and only a single trial was
found for women with detrusor overactivity. At
present it seems that there is no extra benefit in
adding electrical stimulation to PFMT but this
hypothesis needs to be investigated in further
high quality trials.
¥ ES with PFMT versus PFMT alone
1. WOMEN WITH STRESS INCONTINENCE
Four trials compared ES in combination with PFMT
versus PFMT alone in women with stress incontinence
112 , [121],
98 As both arms in these trials
121
85
[85],
[112]
[98].
received the same PFMT the trials are essentially investigating the effect of ES. Two small trials, using faradic
98
stimulation, were reported only as abstracts [121],
121 [98]
and another small trial gave minimal detail of participants, methods and stimulation parameters [85].
85 In a
three arm RCT Knight et al [112]
112 compared PFMT versus PFMT with home based low intensity ES versus
PFMT with clinic based maximal intensity stimulation.
Ten of 21 women in the PFMT group, 9/25 women in
the low intensity stimulation group, and 16/24 in the
maximum intensity stimulation group reported cure or
great improvement. All three groups had significant
improvements in pad test after treatment, with no significant differences in the percentage reduction between
the groups. Similarly all three groups had improvements in vaginal squeeze pressure, but there were no
significant differences in improvement.
¥ Comparisons of different methods of ES
1. WOMEN WITH STRESS INCONTINENCE
A single trial [112]
112 compared low intensity with maximal electrical stimulation in women with urodynamic
stress incontinence. Both groups also received PFMT.
There was a trend, across a range of outcomes including
self report of cure or improvement, pad test, and perineometry, for women who received clinic based maximal stimulation to benefit more than women in the low
intensity stimulation group although most differences
were not significant. Long term follow up (12 months)
suggested that women in both groups continued to
improve subjectively, and this was most noticeable in
the group of women who had received the combination
of PFMT and low intensity stimulation. The trialists
speculated that the combination of PFMT and low
intensity stimulation was counterproductive, as the low
intensity stimulation had resulted in conversion of fast
to slow twitch fibers to the detriment of fast-twitch
fibre activity required in response to rapid changes in
intra-abdominal pressure.
112 did not find any clear beneOverall Knight et al [112]
fits of ES in addition to PFMT. This finding is similar
to that of the three small poorly reported trials [85],
85
98 which found no significant differences bet[121],
121 [98],
ween the groups receiving combined ES/PFMT and
PFMT alone.
2. WOMEN WITH DETRUSOR OVERACTIVITY
2. WOMEN WITH DETRUSOR OVERACTIVITY
Bower et al [118]
118 compared the effect of 10 Hz sacral
stimulation via two surface electrodes versus 150 Hz
stimulation via two surface electrodes placed just above
the symphysis pubis. The findings for women with
detrusor overactivity and sensory urgency were presented separately. Both stimulation groups (10 Hz, sacral
electrodes and 150 Hz, symphysis pubis electrodes)
showed significant improvements in the urodynamic
measures of first desire to void and maximum detrusor
pressure although neither group showed any significant
change in maximum cystometric capacity. The same
proportion (44%) of women in each stimulation group
demonstrated a ÔstableÕ bladder post stimulation and
only the 150 Hz group show a significant improvement
in the threshold volume.
In a four arm RCT in women with detrusor overactivi56 investigated the effect of no
ty Berghmans et al [56]
treatment, lower urinary tract exercises alone (reclassified as PFMT for the purposes of this review), electrical stimulation alone, and electrical stimulation in combination with lower urinary tract exercises. The two
main outcome measures were change in the Detrusor
Overactivity Index (DAI) and the Incontinence Impact
Questionnaire (IIQ). The combination therapy group
did not demonstrate any significant changes pre to post
treatment. There were significant improvements in the
PFMT group for the DAI and a positive (but not significant) trend towards improvement in the IIQ. These
findings do not suggest added benefit from stimulation.
591
122 compared once a week and twice
Lobel et al [122]
weekly stimulation in women with detrusor overactivity and did not find any significant differences in any
outcome measured (including leakage episodes and
quality of life) between the groups. Although more than
half the women in the study were improved symptomatically post treatment only 25% were sufficiently satisfied with outcome that they did not wish for further
treatment.
principles of rehabilitating urinary incontinence
through electrical stimulation, and this inconsistency
means direct comparison between studies is extremely
difficult. Overall there is insufficient evidence to determine if ES is better than no treatment in women with
urodynamic stress incontinence or detrusor overactivity. In trials comparing ES with placebo ES in women
with urodynamic stress incontinence the findings of the
two good quality trials using similar stimulation protocols were contradictory. In women with detrusor overactivity there is a trend in favour of ES but the trials are
small and not easily comparable. There is also insufficient evidence to determine if ES is better than medication for women with urodynamic stress incontinence or
detrusor overactivity. There may be no benefit in
adding ES to PFMT although three of the four trials in
this section were small, poorly reported, and used electrical stimulation protocols that have been superseded
by developments in the understanding of electrical stimulation effects.
When reviewing electrical stimulation trials in
general, and trials comparing electrical stimulation protocols in particular, it appears that some
electrical stimulation protocols may be more
effective than others AND/OR some populations
of women receive more benefit from electrical stimulation than others. Both these variables require further investigation.
¥ ES versus medication
It is not clear if any particular ES protocol is more
effective than any other. The variability in the findings
of the trials included in this section may in part be due
to differences in the effectiveness of the wide range of
protocols that have been tested. There are many differences in clinical application that have not yet been
investigated. For example, some clinicians suggest that
ÔactiveÕ ES (i.e. the patient voluntarily contracts the
PFM during stimulation) is better than ÔpassiveÕ ES but
the effect of these two approaches has not yet been evaluated.
1. WOMEN WITH STRESS INCONTINENCE
A single trial [78]
78 compared electrical stimulation
(Interferential) with vaginal oestrogens (Premarin).
Eight of 25 women in the stimulation group reported
they were cured or improved versus 3/24 in the oestrogen therapy group. There was a significant reduction in
leakage on pad test in the stimulation group but not the
oestrogen group. In contrast the maximum urethral closure pressure was significantly increased in the oestrogen group but not the stimulation group. Long-term follow-up (nine months) found that subjectively one of the
eight women in the stimulation group who had reported
cure/improvement post treatment had recurrent symptoms, as did all three women in the oestrogen group
once oestrogen therapy ceased.
Equally it may be that some populations or subgroups
of women benefit from ES more than others. For
example, anecdotal evidence suggests that ES is used
with particular effect for women who are unable to perform a voluntary pelvic floor muscle contraction on initial assessment. However, this observation has not been
investigated to date.
2. WOMEN WITH DETRUSOR OVERACTIVITY
The single trial [86]
86 that compared electrical stimulation and medication (propantheline bromide) in women
with detrusor overactivity with or without urodynamic
stress incontinence did not find any statistically significant differences in outcome (self reported improvement
and urodynamic parameters) between the two groups.
e) Recommendations
Further high quality RCTs, in larger samples and with
long term follow up, are urgently required to investigate all aspects of the use of ES in the treatment of urinary incontinence in women.
With only single small trials comparing electrical
stimulation with medication there is insufficient
evidence to determine if electrical stimulation is
better than vaginal oestrogens in women with urodynamic stress incontinence, or electrical stimulation is better than anticholinergic therapy in
women with detrusor overactivity.
5. WEIGHTED VAGINAL CONES
a) Background
Weighted vaginal cones were developed as a method of
126
strengthening and testing the function of the PFM [126]
(Figure 5). Theoretically, the sensation of Ôlosing the
coneÕ from the vagina might provide strong sensory
feedback and prompts a PFM contraction in order to
retain the cone. Since their introduction a variety of
cones have been developed (i.e. different sizes, shapes
d) Summary
There is a lack of consistency in ES protocols that
implies a lack of understanding of the physiological
592
and weights), they have been in widespread use, and
directly marketed to women through mail order companies. A review that questions the theoretical framework
and effects of vaginal cones on PFM strength has been
published [127].
127
ly similar. Three trials asked women to retain the heaviest cone possible for 15 minutes twice a day [129],
129
[66],
The other two trials recommended 15
96
66 [96].
130 and 20 minutes [64]
minutes [130]
64 per day. The trials
used sets of cones that included nine [129],
129 [66],
66 five
130 [96]
[130],
96 and three weighted cones [64].
64 The mini64
mum cone weight was 20 grams in four trials [64],
129 [130],
130 [66]
66 and the maximum cone weight was
[129],
70 [64],
64 [130]
129 [66].
130 or 100 grams [129],
66
This section reviews the evidence comparing vaginal
cones with no treatment, placebo treatment, or any
other single treatment (e.g. electrical stimulation). For
trials comparing cones and PFMT readers are referred
to the section on PFMT. A rigorous Cochrane systematic review of weighted vaginal cones (VC) has been
128 The following summary of results and
published [128].
the recommendations are based upon the systematic
review. Readers are encouraged to seek out the full
report for details of method, results and discussion.
1. VC VERSUS NO TREATMENT OR TREATMENT
Two trials compared VC with control interventions in
64 and
women with urodynamic stress incontinence [64],
postnatal women with symptoms of urinary incontinen66 In the trial by B¿ et al [64]
ce [66].
64 women in the
control group were offered the use of the Continence
Guard (Coloplast AS), and in the trial by Wilson & Herbison [66]
66 women in the control group continued their
ÒnormalÓ postnatal care. The meta-analysis by Herbison et al [128]
128 reported that VC were significantly better than control treatment for self reported cure and
cure/improvement, although other measures such as
leakage episodes and pad test did not show significant
differences between the groups. B¿ et al [64]
64 found that
VC were better than control for the Leakage Index, but
the groups were not significantly different with regard
to the proportion wanting further treatment.
b) Quality of data
A brief summary of the quality of the trials included in
the systematic review by Herbison et al [128]
128 is presented below.
¥ Random allocation concealment
Of the five trials contributing to this section allocation
concealment was adequate in two [64],
64 [66],
66 and in the
96
remainder [129],
[130],
[96]
it
was
either
unclear if
130
129
allocation was adequately concealed or the authors simply stated that allocation was at ÒrandomÓ.
¥ Masking of participants and assessors
Masking of participants was not possible in any of the
included trials. Masking of outcome assessors was
66 In the
clearly stated in two of the five trials [64],
64 [66].
remainder this was not reported.
There is level 1 evidence that weighted vaginal
cones are better than control treatments for self
reported cure/improvement women with urodynamic stress incontinence or postnatal women
with symptoms of urine leakage.
¥ Sample size and power calculation
2. VC WITH PFMT VERSUS PFMT ALONE
In two trials the size of the study population was based
64 [66].
on a power calculation [64],
66 One trial randomised
more than 50 women to each comparison group [66],
66 in
64
three trials the group sizes ranged from 25 to 49 [64],
[129],
130 and the remaining trial allocated less than
129 [130],
25 women to each comparison group [96].
96
¥ Losses to follow up
Two trials compared combined VC/PFMT with PFMT
alone [130],
66 and these trials were considered to
130 [66]
have investigated the effect of VC. The systematic
review of Herbison et al [128]
128 found that there was no
overlap in the outcomes measured in these trials and
that no significant differences between groups was
found in either study.
The proportion of dropouts was 10% or less in one trial
64 to
129 and in the remainder it varied from 12% [64]
[129],
130 [66].
66
37% [130],
There is level 1 evidence that there is no benefit
in the addition of weighted vaginal cones to a
PFMT program.
¥ Long term follow-up
3. VC VERSUS PFMT
Two of the five trials followed women up beyond the
66 two to
129 six months, [66]
post treatment evaluation [129]
four years.
(Readers are referred to the section on PFMT. Section
III. 2C)
c) Results
4. VC VERSUS ES
Three trials have compared VC with ES in women with
urodynamic stress incontinence [64],
96 and women
64 [96]
with symptoms of predominantly stress incontinence
¥ VC protocols
Unlike PFMT and ES, the VC protocols were relative-
593
[129].
129 In addition to VC or ES women in both arms of
the RCT by Olah et al were given a PFMT program.
The meta-analysis by Herbison et al [128]
128 did not find
any significant differences between the VC and ES
groups with respect to self-report of cure/improvement,
leakage episodes, or improvement in pad test. B¿ et al
[64]
64 also reported no differences between the groups
for additional outcomes such as the Social Activity
Index, Leakage Index, or the proportion wanting further
treatment.
Six trials [64],
122 [117],
119 investiga86 [119],
64 [83],
83 [122],
117 [86],
ting electrical stimulation or placebo stimulation reported 44 adverse events in ES groups (e.g. leg tremor,
vaginal discomfort or bleeding) and nine adverse events
in placebo ES groups (e.g. disagreeable feeling). Four
trials that included comparisons of VC reported 39
adverse events associated with treatment including aesthetic dislike of the device, discomfort associated with
prolapse or insertion, and problems maintaining moti77 [129].
129
65 [77],
vation [64],
64 [65],
There is level 1 evidence that weighted vaginal
cones are no better than electrical stimulation in
the treatment of women with urodynamic stress
incontinence or symptoms of stress incontinence.
Overall, recording and/or reporting of adverse
events was poor. From the evidence available it
appears that adverse events associated with
PFMT were rare, but more common with VC, ES
or placebo ES.
d) Summary
6. OTHER FACTORS AFFECTING OUTCOME
While there is considerable similarity in the trials investigating the effect of VC, there were few trials in total.
Most of the trials were small and some were of poor to
moderate quality. While treatment with VC may be better than control treatment, it seems that it may be no
better or worse than electrical stimulation. The addition
of VC to a PFMT program may add no further benefit
over PFMT alone.
All included studies were examined for analysis of factors that may have affected the outcome(s) of intervention. Eighteen studies discussed one or more characteristics of the sample population that might have affected outcome [132],
83
65 [133],
133 [105],
132 [120],
120 [71],
71 [65],
105 [83],
[78]
50 [73],
116 , [50],
79 , [112]
74 [116]
73 [117],
117
112 , [74],
85 [79]
78 , [85],
[76],
76 [119].
119
e) Recommendations
The three most commonly mentioned factors (five trials
each) were initial severity of incontinence, age of participants and motivation/compliance with intervention.
Three trials found that severity did not predict response
71 [83],
83 [78],
78 the findings of one trial
to treatment [71],
suggested that women with more severe leakage were
85 and one further trial found
less likely to improve [85],
that responders to intensive PFMT were women with
132 . Three trials suggested
more severe incontinence [132]
that there was no association between age and outcome
78 [85],
85 [68],
68 another found that cure/improvement
[78],
73 while another trial
was less likely in older women [73],
found that responders to intensive PFMT were likely to
132 .
be older [132]
Further high quality, large RCTs, are required to substantiate the effect of training with VC in the management of female urinary incontinence.
f) Adverse effects
All trials referred to in this section were scanned for
records of adverse events associated with treatment.
Thirty-seven trials made no statement about adverse
104 [105],
105
120
effects [123],
[63],
[118],
[104],
123
118 [71],
71 [120],
63
[67],[91],
95 [74]
78 [84],
112 [95],
74 , [50],
50
106 [112],
67 91 [78],
84 [85],
85 [106],
[72],
108
111 [108],
107 [111],
69 [125],
97 [130],
125 [107],
72 [73],
73 [97],
130 [69],
66 [96],
109 [121],
121 [98],
82 [75].
75
[109],
98 [81],
81 [76],
7 [66],
96 [82],
76 [7],
One trial had recorded adverse events but these were
not reported in the abstract of the trial [80].
80
With regard to motivation/compliance all five trials
found a similar association. That is, responders either
seemed to be more motivated [132]
132 or showed greater
76 Two trials,
levels of compliance [68],
117 [76].
68 [73],
73 [117],
included in the comparison of intensive versus standard
PFMT, compared groups that did or did not receive
audiotapes to assist with home training. One of these
trials found that the audiotape group was more compliant with PFMT [67]
72
67 whereas the other did not [72].
Authors of another trial, comparing ES with PFMT,
commented that women appeared to be more compliant
with clinic based ES than home PFMT and speculate
that this is because women are impressed by the stimulator used in treatment [74].
74
Five trials stated that no participant reported adverse
116
events associated with treatment [102],
[115],
[116],
115
102
114
[114].
Three trials reported adverse events but only in the non
79 medication
physical therapy groups, i.e. surgery [79],
131
[70],
and
anti-incontinence
device
[131].
70
Ten trials did report adverse events associated with
83 [77],
77 [68],
68
64 [65],
physical therapy treatments [64],
65 [83],
117
122
[122],
[129],
[86],
[119].
119 Six women reported
86
129 [117],
adverse effects associated with PFMT (e.g. uncomfortable feeling during exercise) in the trial by Lagro-Jans68
sen et al [68].
594
Duration of symptoms and urodynamic parameters
were discussed by four trials each. Two trials found that
women with a longer history of symptoms responded
better to intensive PFMT [132]
132 or maximal electrical
112 whereas Hofbauer et al [85]
stimulation [112],
85 and
Lagro-Jansen et al [68]
68 reported that duration of symptoms had no effect on outcome. Such a wide range of
urodynamic parameters has been reported it is difficult
to see any pattern emerging to date. Ferguson et al
[105]
105 did not find that initial maximum urethral closure pressure was associated with outcome, however B¿
& Larsen (1992) [132]
132 reported that responders to
intensive PFMT were more likely to have a negative
closure pressure initially. Neither of these trials found
an association between functional urethral length and
133 reported that the outoutcome. Elser et al (1999) [133]
come of their trial comparing behavioural training,
PFMT or combined therapy in women with detrusor
overactivity with or without urodynamic stress incontinence was independent of urodynamic diagnosis. In the
course of searching for trials for inclusion in this review
an abstract of an RCT, comparing the outcome of
conservative management based on urodynamic or
134 Ramsay found
symptom diagnosis, was located [134].
that there was no difference between the groups for
cure/improvement post treatment.
and/or compliance with the intervention. It should be
noted that the association between compliance with
physical therapy interventions and improvement might
not be due to the effect of the intervention alone but
some other unknown factor. For example, trial participants who are compliant with active or placebo drug do
better than those who are not compliant with either active or placebo medication (The Coronary Drug Project
Research Group, 1980). Essentially, further investigation of all the above factors is required in subsequent
high quality RCTs before any real conclusions may be
drawn.
DeLancey [135]
135 makes a compelling argument for
intervention for urodynamic stress incontinence to be
based on accurate diagnosis of the underlying pathology, whether it be neurological, ligamentous/fascial, or
muscular. For example, he suggests that PFMT may be
inappropriate where innervation of the muscles is not
intact or where the muscles have been detached from
their fascial connections. A similar argument (for a different set of underlying pathologies) could be made for
urge incontinence. Accurate diagnostics may be more
important than other factors for predicting success of
physical therapies. However current diagnostic procedures, such as urodynamics, do not seem to be able to
reliably predict outcome.
Three trials each referred to the effect of previous surgery or initial PFM strength. No effect was found for
85 urethral susprevious surgery (type unspecified) [85],
pensions [71],
71 or previous pelvic floor repair or hyste50 reduction
rectomy [78].
78 In the trial by Miller et al [50]
in leakage one week after beginning PFMT (the
ÔKnackÕ) was not related to the initial findings from
digital assessment of PFM. In contrast Knight et al
112 found that women who responded best to maxi[112]
mal electrical stimulation had weaker PFM, and B¿ &
Larsen [132]
132 reported that women who responded to
intensive PFMT had stronger PFM initially.
Many of the factors traditionally supposed to
affect the outcomes of physical therapy interventions (e.g. age, severity of incontinence) may be
less crucial than previously thought. The single
factor that is consistently associated with positive
outcome is greater motivation and/or compliance
with the intervention. At present there is no
convincing evidence of the need for urodynamic
evaluation to confirm diagnosis prior to conservative management.
7. PREVENTION
A range of other factors was reported by one or two stu78 found that mild genito-urinary
dies. Henalla et al [78]
prolapse seemed to have no effect on outcome, as did
85 Lagro-Janssen et al [68]
68 stated that
Hofbauer et al [85].
psychological features appeared to have no effect on
132 reported that responders
outcome. B¿ & Larsen [132]
to intensive PFMT had higher BMI, but that the following factors had no effect Ð parity, maximum birthweight of babies, maternal weight gain in pregnancy,
menopausal status, previous PFMT, and family history
of stress incontinence.
a) Background
PFMT has long been recommended to prevent or delay
the onset of both urinary and faecal incontinence, in
44
particular during pregnancy and after childbirth [44],
[43].
43 However there are few published reports of trials
investigating the effectiveness of PFMT and/or other
physical modalities for the primary prevention (preventing incontinence occurring by removing its causes) or
secondary prevention (detecting asymptomatic dysfunction early and treating it to stop progression) of
incontinence.
In summary, many of the factors traditionally supposed
to affect outcomes of physical therapy interventions
(e.g. age, severity of incontinence) might be less crucial
than previously thought. From the trial reports available
the single factor that consistently appeared to be associated with positive outcome was greater motivation
This subsection will examine the evidence for PFMT
and/or other physical modalities used for the primary or
secondary prevention of incontinence. A rigorous
Cochrane systematic review of 10 trials investigating
595
also undertaken at six months but no data was reported
[42].
42 Four trials had baseline, intermediate and end141 [143]
143 and three of these
139 [141],
point measures [139],
studies recruited women during pregnancy [139],
139
[141],
141 [142].
142 Meyer et al recruited women during pregnancy, randomised them to intervention or control
groups at two months after delivery, and evaluated outcome at 10 months postpartum [139].
In the trial by
139
141 antenatal women were recruited at 18Reilly et al [141]
20 weeks gestation, and then followed up at 34 weeks
gestation and three months postpartum. Sampselle et al
recruited women at 20 weeks gestation and repeated
their measures at 35 weeks gestation, six weeks, six and
twelve months postpartum [142].
Finally, Sleep &
142
143 recruited women within 24 hours of deliGrant [143]
very and followed them up at both ten weeks and three
months postpartum. With respect to these four trials the
findings reported in the results are those from the last
assessment point.
physical therapies for the prevention of incontinence is
128 The following summary of
currently in press [128].
results and the recommendations is based on the findings of the currently unpublished review. Readers are
encouraged to seek out the full publication in the
Cochrane Library for details of the method, results and
discussion.
b) Quality of data
A brief summary of the quality of ten [136],
136 [137],
137
140 [42],
138 [139],
[138],
[143],
144 of
139 [140],
141 [142],
142
143 [144]
42 [141],
the 11 trials included in the systematic review by Her128 is presented below. One
bison and Hay-Smith [128]
trial, included by Herbison & Hay-Smith, has been
excluded from the summary presented here, as it was a
145
study undertaken in men [145].
¥ Random allocation concealment
Of the ten trials random allocation concealment was
142 [144]
144 and in one it was inadeadequate in two [142],
quate (i.e. alternation) [140].
140 The remaining seven trials
stated only that group allocation was at random.
c) Results
Only four of the 10 trials reported urinary or faecal
incontinence as an outcome measure [141],
[143],
143
141
[142],
142 [139]
139 and the remainder assessed principally
changes in PFM ÔstrengthÕ [140],
[144],
138
144 [137],
140
137 [138],
136 [42].
[136],
42
¥ Masking of participants and assessors
Two trials stated that assessors of outcome were mas142 [144],
ked to group allocation [142],
144 and in one trial
assessors were not masked [143].
None of the remai143
ning seven trials stated whether the assessor was masked or not.
¥ Preventing incontinence
All four trials investigated the effect of PFM rehabilitation on the prevalence of postpartum incontinence.
Sampselle et al [142]
142 enrolled primigravid women at 20
weeks gestation, and randomised them to receive tailored PFMT program (a correct voluntary pelvic floor
muscle contraction was checked and 30 contractions
per day at or near maximal intensity recommended) or
routine antenatal and postnatal care. Controlling for
baseline incontinence the prevalence of urinary incontinence was significantly less in the PFMT group than
the control group at 35 weeks gestation (p=0.043), six
weeks postpartum (p=0.032) and six months postpartum (p=0.044). By 12 months there was no significant
difference in the prevalence of urinary incontinence
between the groups. In the trial by Sleep & Grant [143]
143
postnatal women were recruited within 24 hours of
vaginal delivery and randomised to receive either a
reinforced PFMT program (daily visits by midwifery
co-ordinator while in hospital to reinforce PFMT instruction) or routine care. Routine care included small
group teaching on PFMT run by obstetric physiotherapists on the postnatal wards, any information received
on PFMT during antenatal education, and leaflets on
PFMT. More women in the reinforced PFMT group
gave a history of antenatal incontinence symptoms
(32% versus 29% in the routine care group) and reported doing antenatal PFMT (57% versus 46% in the rou-
¥ Sample size and power calculation
143 Trials
One trial reported a power calculation [143].
varied in size, and in four there were less than 25 participants per comparison group [136],
144
136 [138],
138 [42],
42 [144].
Three trials randomised more than 50 participants per
143 and one of these was a large
141 [143]
group [139],
139 [141],
143
trial with 900 women in each comparison group [143].
¥ Losses to follow up
Two trials had no losses to follow up or withdrawals
136 [137].
[136],
137 In one trial the drop out rate was less than
10% [138]
138 and in six trials the drop out rates ranged
140 [143]
143 to 36% [142].
from 11% [140],
142 Data on drop outs
141 as it
were not available from the remaining trial [141]
was reported as a study in progress.
¥ Post treatment follow-up
Three trials assessed women at trial entry and then once
137
144 12 weeks [137]
after intervention, at six weeks [144],
138 Dougherty et al [136]
and six months [138].
136 and Niel140 assessed women after six and eight week
sen et al [140]
intervention periods respectively, but also followed up
a proportion of their sample later at two to 18 months
140 The abstract by Norton &
136 and eight months [140].
[136]
42 implied that women were assessed after a
Baker [42]
four week intervention period, and that follow up was
596
However at 10 months postpartum 20/26 women in the
re-education group no longer had stress incontinence
symptoms versus 1/9 in the control group.
tine care group). At three months 180/816 women
(22%) in the reinforced PFMT group and 175/793
women (22%) in the routine care group had urine leakage symptoms. Twenty one and 22 women from each
group respectively had occasional faecal loss. Meyer et
al [139]
139 recruited primparae during pregnancy, and then
at two months postpartum randomised them to receive
either routine care or 12 sessions of biofeedback and
electrostimulation with physiotherapists trained in pelvic floor re-education. No details of the routine care,
biofeedback or electrical stimulation are reported in the
abstract. At two months postpartum nine women in the
control group and 26 women in the re-education group
had symptoms of stress incontinence. At 10 months
postpartum the figures were eight and six respectively.
At 10 months the number of women with faecal incontinence was three and two in each group respectively. In
an abstract of a trial in progress Reilly et al [141]
141 reported on data from 53/150 primigravid women three
months postpartum. Only primigravid women without
any previous urinary incontinence or neurological
disorder were included in the trial, and randomized to
receive a PFMT program supervised by a physiotherapist or no treatment. In the preliminary analysis subjective reports of stress incontinence were more common
in the no treatment group (14/33) than the PFMT group
(2/20) at three months postpartum.
¥ Measures of PFM activity
1. PFMT VERSUS CONTROL TREATMENTS
In a small trial of 35 nulliparous women, without any
indication of pelvic floor muscle dysfunction and no
144 investigated
history of incontinence, Thorp et al [144]
the effect of a six week thrice daily PFMT program
(versus no intervention) on surface EMG measures
from vaginal and anal plug electrodes. There were no
differences between the groups for either maximal or
sustained vaginal or rectal EMG measurements after
training.
140 recruited primiparous women at 33
Nielsen et al [140]
weeks gestation and randomised them to receive usual
antenatal/postnatal care (including encouragement to
perform daily voluntary pelvic floor muscle contraction) or a PFMT comprising 50 brief maximal contractions twice a day for the last eight weeks of pregnancy.
The trial report did not state if any of the women had
previous incontinence symptoms. Both groups had
significant improvements in vaginal squeeze pressure
over the last weeks of pregnancy, and a significant
decrease at eight weeks postpartum compared with the
baseline measure. At eight weeks postpartum the PFMT
group had significantly greater vaginal squeeze pressure than the control group. This finding remained in a
subgroup of women (rural women) who were followed
up at eight months postpartum.
In summary, only one of the trials [141]
141 is a purely primary or secondary prevention trial. As the full report of
this study was not available at the time of writing no
further interpretation of the findings is possible. The
other three trials in this section included women with
existing incontinence symptoms. In some respects these
trials might be better classified as early intervention
studies rather than prevention studies.
Norton & Baker [42]
42 randomised postnatal women six
weeks after vaginal delivery to one of three arms,
control (posture and lifting taught), PFMT (control
intervention plus single teaching session and home program of 100 contractions per day) or vaginal cones. No
participant had pre pregnancy leakage, half had leakage
in pregnancy, and a third postpartum leakage. It was
difficult to extract any useful data from the abstract of
this trial in progress. From the third of participants who
had completed the study it appeared that there were no
significant changes in introital and vaginal squeeze
pressures in the control group but a significant improvement in introital pressure in the PFMT group after
four weeks of training.
As yet, it is not clear what effect PFMT or (undefined)
pelvic floor re-education has on the prevention of urinary or faecal incontinence in antenatal or postnatal
women. Sampselle et al [142]
142 appeared to show benefit
of PFMT over routine care in the early postpartum period but the difference in prevalence of incontinence between groups was no longer significant at 12 months.
This was the only one of the three trials to state specifically that a correct voluntary pelvic floor muscle
contraction was checked prior to training. In contrast,
143 did not show any
the large trial by Sleep & Grant [143]
difference between reinforced PFMT and routine care
(that did include usual advice on PFMT) on the prevalence of urinary or faecal incontinence at three months
postpartum. It is possible that there was not sufficient
difference between the interventions to demonstrate
differences in effect on incontinence. Overall Meyer et
139 did not show that there was any difference in
al [139]
prevalence of urinary or faecal incontinence between
routine care and pelvic floor re-education groups.
In a small three arm trial Dougherty et al [136]
136 randomised [45]
45 postpartum women six to seven weeks after
vaginal delivery to control (sitting with intravaginal
resistance device insitu with no voluntary pelvic floor
muscle contraction, although these were allowed at
other times), PFMT (alternating days of strength and
endurance training six days a week for six weeks), or
PFMT with intravaginal resistance device in situ. All
groups demonstrated improvement in maximum and
sustained vaginal squeeze pressure after six weeks.
597
Although there were greater improvements in both
PFMT groups there were no significant differences between the three groups.
might be significantly greater in the cones group after
four weeks of training, although the difference between
the groups might disappear by six months.
To date, the trials in this area are small. In addition one
trial was in progress at the time of reporting and data
were therefore incomplete. It is difficult to combine the
findings from the individual studies. The following statements should be viewed only as hypotheses to be tested, that (a) there may not be significant gains in PFM
ÔstrengthÕ in nulliparous women without incontinence
symptoms or other pelvic floor dysfunction, (b) that
PFMT is better than control treatment (no treatment or
routine care) to increase PFM ÔstrengthÕ in women after
vaginal delivery.
In summary, it is not clear if there is any difference in
the effectiveness of PFMT or training with cones to
increase PFM ÔstrengthÕ in postnatal women. Although
it appears both methods of training may result in improvements in ÔstrengthÕ two of the trials use cone weight
as the measure of strength and this may advantage the
groups training with cones. As these women have
ÔpracticedÕ the action of retaining a cone, this measure
may be of familiarity and practice with the device,
rather than ÔstrengthÕ.
d) Summary
2. PFMT VERSUS WEIGHTED VAGINAL CONES
There is lack of evidence about the effectiveness of
PFMT or other PFM rehabilitation programs (e.g. electrical stimulation) for the prevention of urinary or faecal incontinence. The absence of long term follow-up in
any of the included RCTs is disappointing. There are
some trials investigating the effect of PFMT and/or
vaginal cones on PFM ÔstrengthÕ. These trials are evaluating, at best, a surrogate end point. PFMT may be
better than control treatments (no treatment or routine
care) at improving PFM ÔstrengthÕ in postnatal women
but this should be considered a hypothesis to be tested
further. It is not clear if there are greater improvements
in ÔstrengthÕ after PFMT or training with vaginal cones
in postnatal women.
Three trials compared PFMT with weighted vaginal
cones in postnatal women [137],
137 [138],
138 [42].
42 Jonasson
et al [137]
137 recruited women at eight weeks postpartum
and randomised them to a 12 week program of either
PFMT (voluntary pelvic floor muscle contraction in a
variety of positions progressing to a maximum of 90
contractions twice a day) or vaginal cones (retain heaviest cone possible in standing/walking for 15 minutes
twice a day). There was no statement in the trial report
about previous incontinence symptoms. The heaviest
cone that could be retained was chosen as the measure
of PFM ÔstrengthÕ. Women in both groups, who could
initially retain 20 to 30g cones initially, had significant
improvements in ÔstrengthÕ with greater improvements
in the cones group. Among women who could initially
retain cones weighing 40g or more, only the cones
group showed significant improvements in ÔstrengthÕ.
138 randomised health
In a later trial, Jonasson et al [138]
postnatal women following vaginal delivery to a six
month program of either PFMT (program as previously) or cones (retain heaviest ÔballÕ possible for 30
minutes per day). Once again, the heaviest cone that
women were able to retain during two minutes of standing/walking measured PFM ÔstrengthÕ. ÔStrengthÕ
improved significantly in both groups with greater
42
improvement in the cones group. Norton & Baker [42]
randomised postnatal women six weeks after vaginal
delivery to one of three arms, control (posture and lifting taught), PFMT (control intervention plus single
teaching session and home program of 100 contractions
per day) or vaginal cones (no details given). It was not
clear from the abstract if the cones group also received
the control and PFMT interventions. Norton & Baker
[42]
42 did state that no participant had pre pregnancy leakage, half had leakage in pregnancy, and a third postpartum leakage. It was difficult to extract any useful
data from the abstract of this trial in progress. From the
third of participants who had completed the study it
appeared that introital and vaginal squeeze pressures
e) Recommendations
Further high quality RCTs, with long term follow-up,
investigating the effectiveness of physical therapies for
the prevention of urinary incontinence in women at
risk, or in the general female population, are urgently
required. It is worth noting that the Cochrane Review
by Herbison & Hay-Smith [128]
128 has identified two
trials in progress investigating the effect of PFMT in the
prevention of incontinence and readers are referred to
the review for further details.
IV. BLADDER RETRAINING
1. INTRODUCTION
The section examines the evidence on the use of bladder retraining in cognitively intact, noninstitutionalized
women with urge, stress, and mixed incontinence, and
provides recommendations for its effective use in clinical practice. A summary of the search strategy and
inclusion/exclusion criteria for selecting studies for
review is provided in the Appendix. See the section on
conservative therapy in the elderly for a detailed discussion of the other types of scheduled voiding regi-
598
mens that are used in management of urinary incontinence in women who are cognitively impaired and/or
institutionalized.
Bladder retraining programs typically involve several
key elements: patient education on the mechanisms
underlying continence and incontinence; a scheduled
voiding regimen with gradually progressive voiding
intervals; urgency control strategies using distraction
and relaxation techniques; self-monitoring of voiding
behavior; and positive reinforcement provided by a clinician [156].
156 Bladder retraining requires a cognitively
intact and motivated patient who is capable of independent toileting and can adhere to the scheduled voiding
regimen.
Several systematic reviews on bladder retraining with
147
146 [147],
qualitative synthesis have been published [146],
148 Recently, the Cochrane Collaboration published
[148].
an updated review of Bladder Training for Urinary
Incontinence in Adults which graded the quality of the
included studies with respect to treatment of urge
149 To date, there has been no
incontinence only [149].
other published meta-analysis (quantitative synthesis).
A previous systematic review by Roe, Williams, and
149 involving seven trials on bladder retraiPalmer [149]
ning in the management of urge incontinence alone
concluded that the evidence suggests bladder retraining
may be helpful when compared to no treatment. However, Roe et al cautioned interpretation of this conclusion
because it was based on limited data. The review also
concluded that there was not enough evidence to show
whether drug therapy was better than bladder retraining
or useful as a supplement to it.
2. BLADDER RETRAINING
a) Background
Bladder retraining (also referred to as a bladder discipline, bladder drill, bladder training, and bladder reeducation) is a term used to describe the educational
and behavioral process used to re-establish urinary
control in adults. It was first described by Jeffcoate and
Francis in 1966 as Òbladder disciplineÓ which involved
a program of patient education and a scheduled voiding
regimen used to manage functional disorders of the
150 Later, Frewen in a
lower urinary tract in women [150].
series of articles published from 1972 to 1982 brought
widespread attention to the role of bladder retraining in
the treatment of urge incontinence with or without associated detrusor overactivity and sensory-urgency pro154
152 153],
blems without incontinence [151],
151 [152,
153 [154].
Evidence indicating that bladder retraining was also
effective in women with urodynamic stress incontinence [147]
147 led to clinical practice guidelines in the United
States recommending its use for women with urge,
stress, and mixed incontinence as a first-line of therapy
[155].
155 These recommendations did not require that urodynamic evaluation be performed prior to the initiation
of therapy.
b) Quality of included studies
This updated review from that reported at the First
International Consultation on Incontinence, focuses
only on randomized and nonrandomized controlled
trials. (See the previous review for a comprehensive listing of clinical series evaluating bladder retraining.)
Since the last review, there have been three reports on
bladder retraining; two were not included as they were
retrospective analyses [157],
157 [158].
158
Six clinical trials have been published on the efficacy of
bladder retraining alone in women. Of these, five are
randomized clinical trials (RCTs) [159],
160 [147],
147
159 [160],
[161],
75 involving a total of 626 women; and one
161 [75]
was a nonrandomized controlled trial with a long-term
follow-up [68],
87
68 [87].
Of the RCTs, two compared bladder training to an
untreated control group [159],
147 one RCT compa159 [147],
red bladder retraining to two other behavioral interventions (pelvic floor muscle training augmented with biofeedback or a combination of both therapies) [75];
75 and
two RCTs compared bladder retraining to anticholiner161 Two of these RCTs [147],
147
gic drug therapy [160],
160 [161].
[75]
published
additional
papers
reporting
on
different
75
133 The nonrandotreatment outcomes [162],
163 [133].
162 [163],
mized trial compared bladder retraining for those with
urge incontinence alone or bladder retraining with pelvic floor muscle training for those with mixed inconti68 However,
nence to a no-treatment control group [68].
due to the small number of subjects receiving bladder
training alone (N=9) and the method of reporting, these
results will not be presented [68].
68
Specific goals of bladder retraining include correcting
faulty habit patterns of frequent urination, improving
ability to control bladder urgency, prolonging voiding
intervals, increasing bladder capacity, reducing incontinent episodes, and building patient confidence in
controlling bladder function. The underlying mechanism of how bladder retraining achieves its effects is
poorly understood. Several hypotheses have been proposed including improved cortical inhibition over
detrusor contractions; improved cortical facilitation
over urethral closure during bladder filling, improved
central modulation of afferent sensory impulses; altered
behavior resulting from better individual awareness of
the lower urinary tract function and circumstances that
cause incontinence, and increasing the ÒreserveÓ capability of the lower urinary tract system [147],
[156],
147
156
75
[75].
The age of the study populations ranged from 17 [160]
160
599
to 90 years [147].
147 All studies investigated the effect of
bladder retraining in women with detrusor overactivity,
low compliance bladder, or sensory bladder. Two RCTs
also included women with urodynamic stress incontinence with or without detrusor overactivity [147],
147 [75]
75
and the nonrandomized trial included women with urge
or mixed incontinence [68].
68 Sample sizes ranged from
75 Only one study reported a
50 [160]
160 to 204 women [75].
power calculation [75].
75 All trials had intervention
groups containing 25 or more subjects.
Results of treatment typically occur within two weeks
after commencing treatment [160],
75 The reported
160 [75].
cure rates for reducing urinary incontinence ranges
from 12% to 90% [147]Fantl
et al., 1991; [159]
147
159 depending on how efficacy is measured. Subjective improvement rates measured by the patientÕs self-report are
73% to 90% [159],
159 [161].
161 When using urinary diaries to
evaluate cure rates, the rates range from 12% to 16%
[147],
147 [75].
75 Studies reporting on the long-term effect of
bladder retraining are limited [87].
87
Follow-up periods were variable with all studies
conducting at least on post-treatment assessment within
4-12 weeks of treatment initiation. Several trials included an additional evaluation at 3 to 12 months posttreatment. One study conducted a 5-year follow-up
[87].
87 Outcome measures used included self report of
159 [160],
68
160 [68],
benefit (e.g., cure or improvement) [159],
161 [75],
[87],
75 a urinary diary [147],
87 [161],
161
68 [161],
147 [68],
75 quality of life instruments
147 [75]
[75]),
75 pad tests [147],
75 and urodynamic measures [159],
159
147
[147],
[163],
163 [75],
162 [161],
133 Compliance with the bladder retrai[162],
161 [133].
75
ning protocol was reported in only one study [75].
1. BLADDER RETRAINING VERSUS NO TREATMENT
Bladder retraining as the sole therapy has been used in
the treatment of detrusor overactivity, urodynamic
stress incontinence, mixed incontinence, and urge
incontinence with a stable bladder.
There is Level 1 evidence that bladder retraining
is an effective treatment for women with urge,
stress, and mixed urinary incontinence.
Two RCTs reported significant improvements in the
bladder retraining group as compared to an untreated
159 [147].
147 Jarvis and Millar [159]
159
control group [159],
investigated the effect of an in-patient bladder retraining program in women with a diagnosis of detrusor
overactivity, whereas Fantl et al.,[147]
147 studied the
effect of an outpatient program in women with urodynamic stress incontinence, detrusor overactivity, and
mixed incontinence. Reported cure/improvement rates
varied between the two trials which may have reflected
the different follow-up periods, the type of outcome
measures used, or the bladder retraining protocol. Jar159 reported that 90% of the treatment
vis and Millar [159]
group were continent and 83.3% were symptom free at
6 months; whereas, in the control group 23.3% were
continent and symptom free. All women who were
symptom free after treatment reverted to a normal cystometrogram.
c) Results
¥ Bladder Retraining Programs
Several variations may occur in how bladder retraining
programs are implemented. Variation in the scheduled
voiding protocols range from a mandatory regimen
with restriction of voiding in between assigned toileting
times to a self-scheduling regimen with no restriction of
voiding if urgency becomes unbearable. The initial
assigned voiding interval may vary from 30 minutes to
2 hours with 1 hour being the most common interval;
with the increase in voiding interval from 15 to 60
minutes. Generally, voidings are not required during
sleeping hours. Other variations in retraining programs
involve the setting in which bladder retraining is
conducted; use of adjunctive treatments such as pelvic
floor muscle training or drug therapy; type of urgency
control techniques used; and whether fluid modifications are incorporated into the program. Early protocols
in the United Kingdom required hospitalization for 5159 [160].
160
13 days to ensure strict protocol adherence [159],
Later protocols implemented bladder retraining as an
outpatient treatment program lasting from 6 to 12
weeks [147],
75 Techniques of urgency control inclu147 [75].
de a variety of distraction and relaxation techniques
such as deep breathing exercises, mathematical problem solving and other attention tasks, positive self-statements, perineal pressure, and use of pelvic floor
muscle contraction to control a specific urge. Fluid
modifications such as an increase or decrease of fluid
intake or a change in timing of fluid intake were not
generally recommended. Most bladder retraining protocols required self-charting of voiding patterns.
Fantl et al [147]
147 reported that 12% of the treatment
group were continent and 76% had reduced their incontinent episodes at least 50% or more at 6-weeks as measured by a 7-day urinary diary. These results were
maintained at 6 months. They also reported a 55%
improvement in quality of life measured by the Incontinence Impact Questionnaire at 6-weeks which was
maintained over a 6-month period; however, there was
not a direct correlation between improvements on a urinary diary and the Incontinence Impact Questionnaire
[163].
163 Significant reductions were also observed with
diurnal and nocturnal frequency and pad weights.
While some women did revert back to normal bladder
function following training, no relationship was found
between changes in urodynamic variables and the num162 Women with detrusor
ber of incontinent episodes [162].
600
bladder, and 60% of those with sensory bladders. Bladder retraining clinically cured 62% of those with detrusor overactivity, 75% of those with low compliance
bladders, and 81% of those with sensory bladders.
However, the relapse rate at 6-months was higher for
the oxybutynin group, whereas, those in the bladder
retraining group maintained their results better.
Changes in bladder stability corresponded to symptom
improvement in both groups.
overactivity with and without urodynamic stress incontinence had similar reductions in incontinent episodes
and improvements in quality of life.
2. BLADDER RETRAINING VERSUS PELVIC FLOOR MUSCLE
TRAINING
One trial that compared bladder retraining with pelvic
floor muscle training augmented with biofeedback
found that both interventions were equally effective in
reducing incontinent episodes and improving quality of
life in women with urodynamic stress incontinence,
detrusor overactivity, or both diagnoses. In a multi75 cure rates determined by a 7-day uricentre RCT, [75]
nary diary, were reported to be 18% and 16% in the
bladder retraining group at 3 and 6 months post-randomization, respectively, versus 13% and 20% in the pelvic floor muscle training group. Improvement rates
(i.e., percent of patients achieving greater than 50%
reduction of incontinent episodes) in the bladder retraining group was 52% and 46% at 3 and 6 months, respectively, versus 57% and 56% in the pelvic floor
muscle training group. Women with detrusor overactivity with and without urodynamic stress incontinence
has similar reductions in incontinent episodes. Changes
in incontinence severity were unrelated to urodynamic
changes [133].
133
There is Level 1 evidence to suggest that bladder
retraining has similar benefits in women with
detrusor overactivity as drug therapy available
prior to 1996, and may have greater long term
benefit.
d) Summary
There appears to be Level 1 evidence to suggest that for
women with urge, stress, and mixed urinary incontinence that bladder retraining is more effective than no
treatment. Evidence is inconsistent about expected cure
rates which may be dependent on when and how the
outcome was measured or reflect differences in the
bladder retraining protocol. Findings on objective (cystometric) changes do not always correspond to successful subjective change.
One RCT has indicated that bladder retraining
and pelvic floor muscle training have similar efficacy in women with urge, stress and mixed incontinence and this finding requires further investigation.
One RCT has indicated that bladder retraining and pelvic floor muscle training have similar efficacy; this finding requires further investigation. Bladder retraining
appears to have similar benefits as drug therapy available prior to 1996 and may have greater long term
benefit.
3. BLADDER RETRAINING VERSUS MEDICATION
e) Recommendations
Two RCTs concluded that bladder retraining was superior to anticholinergic drug therapy in women with
160 found that inpatient
detrusor overactivity. Jarvis [160]
bladder retraining was superior to an outpatient program of combined drug therapy of 200 mg (three times
a day) flavoxate hydrocholoride and 25 mg (three times
a day) imipramine. Cure/improvement rates in the bladder retraining group were 84% subjectively continent
and 76% symptom free versus 56% continent and 48%
symptom free in the drug therapy group. Patients who
were symptom free at 4 weeks were able to maintain
their effects at 12 weeks. Cystometric changes in both
groups were related to the clinical changes.
Bladder retraining should be offered as therapy to
women with urge, stress, and mixed urinary incontinence.
GRADE OF RECOMMENDATION: A
There is a lack of consistency in bladder retraining
protocols. On the basis of extrapolation from the
bladder retraining literature, an outpatient retraining
protocol should include an initial voiding interval
typically beginning at 1 hour during waking hours,
which is increased by 15-30 minutes per week depending on tolerance of the schedule (i.e., fewer incontinent episodes than the previous week, minimal interruptions to the schedule, and the womanÕs feeling of
control over urgency), until a 2-3 hour voiding interval is achieved. A shorter initial voiding interval, i.e.,
30 minutes or less, may be necessary for women
whose baseline urinary diaries reveal an average voiding interval of less than 1 hour. Education should be
161 reported that a 6Columbo and his associates [161]
week course of oxybutynin had a similar clinical cure
rate (e.g., self-reported total disappearance of urge
incontinence, no protective pads, or further treatment)
as bladder retraining (74% versus 73% respectively).
Oxybutynin clinically cured 93% of patients with detrusor overactivity, 67% of those with low-compliance
601
[165],
166 and one RCT compared an inpatient to an
165 [166]
outpatient program consisting of bladder retraining and
94 One non-randomized
pelvic floor muscle training [94].
controlled trial compared anticholinergic drug therapy
with bladder retraining to bladder retraining with place167 and the other compared bladder retraining for
bo [167],
women with urge incontinence and bladder retraining
and pelvic floor muscle training for women with mixed
68
incontinence to a control group [68].
provided about normal bladder control and methods
to control urgency such as distraction and relaxation
techniques and pelvic floor muscle contraction. Selfmonitoring of voiding behavior using urinary diary
or treatment log should be included in order to determine adherence to the schedule, evaluate progress,
and determine whether the voiding interval should
be changed (Figure 6). Clinicians should monitor
progress, determine adjustments to the voiding interval, and provide positive reinforcement to women
undergoing bladder retraining at least weekly during
the training period. If there is no reduction in incontinent episodes after three weeks of bladder retraining, the patient should be re-evaluated and other
treatment options considered. Inpatient bladder
retraining programs may follow a more rigid scheduling regimen with progression of the voiding
interval on a daily basis.
a) Background
94 to
The age of the study population ranged from 26 [94]
166 Some trials included a few men, and it was
98 [166].
not possible to determine the effect on women only
[166];
166 56 women and 4 men. All studies with the excep75 investigated the combined effect of
tion of one trial [75]
bladder retraining with another intervention which may
have included a placebo treatment in women with
detrusor overactivity, urge incontinence with stable
detrusor function, or urge incontinence without known
detrusor dysfunction, or sensory bladder. In the one
exception, women with urodynamic stress incontinence, detrusor overactivity and/or both diagnoses were
75 Sample sizes ranincluded in the study population [75].
ged from 20 [79]
79 to 204 women [75].
75 All but one RCT
had intervention groups containing 25 or more subjects
[164].
164 Two studies reported power calculations [79],
79
[75],
but
only
one
study
achieved
statistical
power
[75].
75
75
Outcome was measured most frequently by subjective
165 [166],
report of cure or improvement [164],
166 [68],
68
164 [165],
[94],
and
urinary
diary
[79],
[164],
[165],
[87],
87
165
164
94 [75]
79
75
79
[94],
[75],
94
75 followed by urodynamic measures [79],
[164],
pad test
164 [133],
75
133 quality of life evaluation [75],
94 and cost [94].
94 Three studies reported on com[94],
pliance in the assessment of treatment outcome [68],
68
[166],
75
166 [75].
Bladder retraining has been used in combination with
pelvic floor muscle training, bladder biofeedback,
estrogen replacement therapy, and anticholinergic drug
therapy in the management of urge, stress, and mixed
incontinence. Refer to Section 2 (c) for discussion of
bladder retraining protocols.
Follow-up periods were variable with most studies
conducting at least one post-treatment assessment
within five days to three months following treatment
initiation. One trial included an additional evaluation at
six months post-randomization[75].
75 Longer-term fol87
low-up was completed in one study [87].
b) Quality of the data
c) Results
GRADE OF RECOMMENDATION: C
Further RCTs are needed that compare bladder retraining alone to lifestyle interventions, pelvic floor
muscle training, and drug therapies in the management of stress, urge, and mixed incontinence. Studies
are also needed to determine the long-term efficacy
of bladder retraining.
3. BLADDER
RETRAINING IN COMBINATION
WITH OTHER ADJUNCTS
(PELVIC
FLOOR
MUSCLE TRAINING AND MEDICATIONS)
¥ Bladder Retraining with Pelvic Floor Muscle
Training Versus Bladder Retraining Alone, Psychotherapy, or Drug Therapy
Only one trial was found that compared bladder retraining to a combination behavioral intervention program
(bladder retraining and pelvic floor muscle training).
Although combination therapy resulted in greater reductions in incontinent episodes and improvements in quality of life at three months post-randomization, the
results suggest that bladder retraining is as effective as
combination therapy when evaluation occurs six months
post-randomization. In WymanÕs previously cited study
75 cure rates as determined by a 7-day urinary diary
[75]
Seven studies were reviewed that compared bladder
retraining with other interventions including placebo
164 [165],
interventions. Of these, five are RCTs [164],
165
166
94
75 involving 394 women; and two are
[166],
[94],
[75]
68
167 [68].
nonrandomized controlled trials [167],
One RCT compared bladder retraining with pelvic floor
muscle training to bladder retraining alone or pelvic
75
floor muscle training alone [75];
one RCT compared
bladder retraining with pelvic floor muscle training to
164
psychotherapy and anticholinergic drug therapy [164]
two RCTs compared bladder retraining with anticholinergic drug therapy to bladder retraining with placebo
602
Figure 6 a, b : Bladder retraining self-monitoring
at 3 months post-randomization were 31% in the combination therapy group, whereas it was 18% in the bladder retraining group. Improvement rates (i.e., 50% or
greater reduction in incontinent episodes) were 70% in
the combination therapy group, whereas they were 51%
in the bladder retraining group. However, by 6 months
post-randomization, both cure and improvement rates
in combination therapy had dropped (27% and 59%,
respectively), whereas cure and improvement rates
were better maintained in the bladder retraining group
(16% and 41%, respectively). Women with urodynamic
stress incontinence or detrusor overactivity with and
without stress incontinence had similar reductions in
incontinent episodes at the 3 and 6 months post-randomization evaluations.
drug therapy groups at 12 weeks post-treatment initiation. Improvement in the bladder retraining group was
associated with cystometric improvements in detrusor
pressure.
An RCT that compared an impatient to an outpatient
program of bladder retraining and pelvic floor muscle
training reported that an outpatient program was as
effective and could be conducted at less cost [94].
94 Subjective cure/improvement rates were 63% in both
groups, dry pad testing had similar rates in inpatients
(70%) as outpatients (77%), and cure rates at 3 months
(defined as no incontinent episodes on a urinary diary)
were similar in inpatients (63%) versus outpatients
(53%).
¥ Bladder Retraining with Drug Therapy
The effectiveness of bladder retraining in combination with pelvic floor muscle training as compared to bladder retraining alone is as yet unclear
and further investigation is warranted (Level 1).
Three trials comparing anticholinergic drug therapy
with bladder retraining to bladder retraining with placebo [167],
167 [165],
165 [166]
166 were not consistent with respect
to the additive benefit when combining bladder retraining with anticholinergic drug therapy in the treatment
of detrusor overactivity. Szonyi et al., [166]
166 using a
double-blind placebo controlled, parallel group design
found no difference between 2.5 mg of oxybutynin
twice daily with bladder retraining versus the placebo
group (bladder retraining and placebo) in reducing
incontinent episodes or nocturia. However, the investi-
In another RCT, bladder retraining with pelvic floor
muscle training was compared to brief psychotherapy
or drug therapy (propantheline) in women with detrusor
overactivity and sensory-urgency syndrome [164].
164
Incontinent episodes and nocturia as measured by a 7day urinary diary were significantly reduced in the psychotherapy group but not in the bladder retraining or
603
The effectiveness of adding bladder retraining to
drug therapy and vice versa is unclear, and
requires further investigation (Level 1/2 ).
affect treatment outcome. Two RCTs found that urodynamic diagnosis (urodynamic stress incontinence,
detrusor overactivity, or both) had no effect on treatment outcome whether measured by urinary diaries or
standardized quality of life instrument, and change
back to normal function did not correlate to an improvement in incontinence severity [147],
162 75
147 [162],[75],
[133].
133 However, two other RCTs found that those
patients who became subjectively continent reverted
back to normal detrusor function [159],
159 [160].
160 One trial
found that patients with sensory bladders did better than
those with detrusor overactivity or low compliance
bladders [161].
161 One trial conducting a five-year followup found subjects with urge or mixed incontinence
87
were least likely to maintain their results [87].
d) Summary
5. ADVERSE EFFECTS ASSOCIATED WITH BLAD-
gators concluded that the drug group was superior to
the placebo (bladder retraining) group because it had
greater subjective benefit (86% versus 55%). Another
study using a similar research design reported no difference between the placebo (bladder retraining and placebo) and 25 mg of terodiline with bladder retraining in
reducing incontinent episodes [165].
165 In contrast, one
nonrandomized, double-blinded placebo controlled
design found that terodiline with bladder retraining was
superior to bladder retraining and placebo [167]
167 on both
objective and subjective measures.
DER RETRAINING
The effectiveness of bladder retraining in combination
with pelvic floor muscle training in comparison to bladder retraining alone is unclear, and further investigation
is warranted (Level 1). The one RCT available suggests
that the long-term benefit of bladder retraining alone
may be similar to that of bladder retraining combined
with pelvic floor muscle training. Additional benefit of
combining bladder retraining with drug therapy available prior to 1996 was not consistently noted.
Four of the 12 studies reviewed made a statement about
adverse effects associated with bladder retraining
159 [160],
[159],
147 [161].
161 In these studies, there were
160 [147],
no reported adverse effects. Although the reporting of
adverse effects was poor across studies, it appears that
bladder retraining is safe and acceptable to patients.
V. ANTI-INCONTINENCE DEVICES
IN THE FEMALE PATIENT
e) Recommendations
Further RCTs are needed that compare the additive
benefit of bladder retraining to lifestyle interventions,
pelvic floor muscle training, and drug therapies in the
treatment of urinary incontinence. In addition, research
is needed to determine subgroups of patients who will
derive the greatest benefit from bladder retraining alone
or in combination with pelvic floor muscle training or
drug therapy.
4. FACTORS AFFECTING
1. INTRODUCTION
Urinary loss in the female patient may be the result of
overactivity or underactivity of the detrusor or outlet,
alone or in combination. Devices may act to correct,
compensate for, or circumvent the pathology of the
detrusor or outlet, in order to improve urinary storage
and/or emptying. Varying levels of manual dexterity are
required of the patient, depending on the type of device. For some devices, health care provider intervention
may be necessary for device sizing, training, prescribing, and/or device insertion and replacement at regular
intervals.
OUTCOMES OF BLAD-
DER RETRAINING
Analysis of factors affecting treatment outcome is problematic in most published studies due to low power
with relatively small subgroups. Nine of the 12 trials
reported on factors affecting the outcomes of bladder
retraining. Of these, three trials reported on factors
affecting outcomes associated with bladder retraining
75 One study reporas the sole therapy [147],
147 [161],
161 [75].
ted that age was not a factor in treatment outcome
147 Compliance was mentioned as a factor affecting
[147].
treatment outcome in a small study [68] but not in a larger study comparing the efficacy of bladder retraining
to pelvic floor muscle training alone and combination
behavioral therapy [75].
75
The devices reviewed in this section are not permanently implanted into the female patient, but are extraurethral, intra-vaginal or intra-urethral. The devices
may be disposable or re-usable following each voiding
episode, or may be replaced daily, after several days, or
may be left indwelling for up to 28 days. The Food and
Drug Association (United States FDA) defines a device
as Ônon-implantÕ only if it is left indwelling for less than
28 days. Devices designed for chronic intra-urethral
usage must be replaced within this time interval.
There is conflicting evidence of whether symptomatology, urodynamic diagnosis, or urodynamic parameters
Pessaries, the most commonly utilized devices for prolapse and incontinence, have never been subjected to an
604
excluded from efficacy and quality of life assessments
at the termination of the study. Consequently, many of
the devices which have performed adequately in clinical studies have not achieved acceptance by physicians
and patients in clinical practice, or attained commercial
success. Many of the devices which are included in the
review, have been approved by regulatory agencies but
are no longer marketed.
This sub-chapter will examine the evidence for the
management of urinary incontinence using non-implanted devices in the non-neurogenic female patient. A
summary of the search strategy is given in Appendix 1.
RCT or compared to other devices. Most reports of
device usage, prior to 1995 are descriptive or laboratory based, but more recent studies have provided more
subjective and objective data, and have incorporated
quality of life assessment.
There are four RCTs (two articles and two abstracts)
among the reports published in this section. Device protocols rarely have employed a non-treatment group,
cannot easily employ a ÔplaceboÕ model, and are usually designed as open longitudinal studies, utilizing the
patientsÕ baseline data as the control. Comparison studies between devices are needed, which ideally should
be randomized and ÔcrossoverÕ designed, and one such
study is included. There is only one abstract and one
paper which compares two different devices, no studies
which compare device use to other forms of conservative or surgical therapy, and no publications which
report cost-effectiveness data.
There are an increasing number of more carefully designed studies since the initial review, including 4 RCTs (2 abstracts and 2 papers), but to
date, there is only one abstract and one paper
comparing two different non-implant devices.
There are no studies comparing device use to pad
use or other forms of conservative therapy, or to
surgical intervention. Although there is increasing data supporting the efficacy and tolerability
of intra-vaginal support, extra-urethral occlusive, and intra-urethral devices, there has not been
wide clinical acceptance by physicians or patients
for device use in the ambulatory female population for the treatment of urodynamic stress incontinence.
Urinary incontinence is a Ôquality of lifeÕ issue, and
physician and patient ÒacceptabilityÓ, in addition to the
literature reports of efficacy and safety, have been a
major determinant of clinical and commercial success.
Of note, many devices have demonstrated higher efficacy and quality of life scores during laboratory observation and clinical trial settings, than in clinical practice. A simple explanation may be that health care provider support, during clinical trials, may improve patient
willingness to complete the protocol and improve satisfaction. Patient willingness to perform instrumentation
may vary by device type, the anatomic location of placement, and the perceived level of invasiveness. Prashar [131]
131 utilized a ten item questionnaire, given to
104 consecutive women, and reported attitudes to becoming familiar with genital anatomy and placing devices
into the vagina or upon the urethra. Only 30% of the
women were quite comfortable about the concept of
touching their genitalia and this attitude was age dependent. Only 21% were willing to insert a continence
device into their vagina, varying weakly with age but
significantly affected by previous tampon or diaphragm
usage. Only 15% felt very comfortable about placing a
continence device on to their urethra, and this was not
affected by age and was only slightly more common in
previous tampon users. Older women were less likely
to understand the anatomy of their genitalia or to be
comfortable about the idea of exploring it, but age was
no barrier to willingness to employ a urethral or vaginal
continence device.
2. DEVICES THAT TREAT INCONTINENCE SECONDARY TO FAILURE TO EMPTY (DETRUSOR
UNDERACTIVITY / OUTLET OVERACTIVITY) IN
THE NON-NEUROGENIC ADULT FEMALE
a) Background
Failure to empty the bladder decreases functional bladder capacity. The non-neurogenic adult female may
demonstrate the symptoms and signs of overflow
incontinence. The acute and chronic management of
these patients and the indications for catheterisation are
reviewed in the section on treatment of the neurogenic
patient.
b) Quality of included studies
Treatment for urinary retention may involve an indwelling catheter, intermittent catheterisation, or the monitoring of clinical parameters during continued overflow
voiding. There have been no published studies on the
use of catheter drainage in the ambulatory population.
In a descriptive study of 15 patients, without controls,
168 described a sphincter-pump prosthesis,
Nativ [168]
composed of a self retaining silicone catheter with a
self contained urinary pump (flow 10-12 cc/sec), which
is activated by a small hand-held control device for
bladder emptying (Figure 7 (In-Flow / SRS Medical). A
physician must change the device.
Additionally, the denominator for Ôpatient satisfactionÕ
may not reflect device acceptance in clinical use, since
Ôintent to treatÕ patients, who are initially screened, but
do not want to utilize the device, may not be included
in the patient satisfaction data, and patients who Ôdrop
outÕ of the study due to adverse events or dissatisfaction, may be included in safety data, but are often
605
Figure 7 : Inflow device (clockwise from upper left: hand held control device, device in place, device insertion, device open,
device prior to insertion
3. DEVICES THAT TREAT FAILURE TO STORE
(OUTLET UNDERACTIVITY) IN THE NON-NEU-
c) Results
The In-Flow device improved continence and bladder
emptying in this single report, with minimal morbidity, but the study was short term, and there were no
specific comments on effects of the device on urethral
integrity.
ROGENIC
AMBULATORY ADULT
FEMALE
POPULATION
INTRODUCTION
d) Summary
Failure to store secondary to decreased outlet activity
may be manifested in the symptoms and signs of urodynamic stress incontinence (USI). Treatment of this
condition with devices has been reported utilizing:
Treatment of urinary retention may be accomplished by
observation, indwelling or intermittent catheterisation.
Newer technologies for bladder emptying will require
further study. (Level of evidence: 4).
1) External urinary collection,
2) Intravaginal support of the bladder neck, and
3) Blockage of urinary leakage by occluding egress,
i) at the external meatus, or
ii) with an intraurethral device.
e) Recommendations
Newer technologies, which do not require external collection of urine, utilizing indwelling mechanical urethral valves and pumps, may provide an alternative for
carefully selected patients. This area should be identified as an important topic for future research.
1) External collection devices
a) Background
GRADE OF RECOMMENDATION: D.
The use of pads, diapers and incontinence pants are discussed in page 666. Female external collecting devices
are placed over the urethral meatus or within the introital area, are secured by straps, adhesive or suction, and
empty into an external drainage bag. These devices can
606
be utilized for failure to store secondary to an underactive outlet or an overactive bladder. These devices have
been developed, tested, and a few reports on their use
have been published, but they have not been widely distributed or sold.
¥ Diaphragms / Pessaries:
Realini [173]analyzed
the benefit for one week, in 10
173
selected patients of a coil-type diaphragm ring, which
was softer than a pessary, utilizing diaries and a two
hour pad test. Suarez [174]
174 included urodynamic testing in his evaluation of a contraceptive diaphragm in
175 [176]
176 reported on the urody12 patients. Bhatia [175],
namic effects of a Smith Hodge pessary, and suggested
this as a modality to predict the outcome for bladder
neck support surgery.
b) Quality of included studies
Studies describing devices for the collection of urine in
female patients are descriptive, and were performed on
patients in a rehabilitation center or nursing home, and
not in the ambulatory population. Edwards [169],
169 Bonnar [170],
and Cardozo [171]
170
171 reported on devices of
historical interest, which are not commercially available.
¥ Specific bladder neck support devices:
Included in this category are:
1. Removable reusable intra-vaginal ring, composed of
silastic, and constructed with two prongs which are
placed behind the symphysis to support the bladder
neck (Introl, no current distributor) Biswas [177],
177
178 [179],
179 Moore [180],[181]
Davila [178],
180 181 and Kondo
182 (Figure 8).
[182]
c) Summary
External collecting devices for the ambulatory female
patient are cumbersome and have demonstrated low
efficacy. There are no devices in clinical use.
Previous devices have failed to solve the problems of:
1) sizing, due to variations in anatomy, 2) providing an
effective and comfortable meatal or vaginal locator, 3)
developing an anchoring method with suction and/or
adhesion, that coapts without tissue injury, 4) allowing
duration of usage, and 5) adjusting to the degree of
mobility of the patients (Level of evidence: 5).
The pilot study by Biswas [177],
177 the developer of the
device, was a laboratory study, which employed a
straining cystogram. Following this study, the number of device sizes was increased from 8 to 25. A
variety of different protocols were employed to
study efficacy, safety and satisfaction by Davila
[178],[179],
182 In
180 181 and Kondo [182].
178 179 Moore [180],[181]
general, a voiding diary which specified voiding and
leakage episodes and a one hour pad weight test
(PdWt-1hr) were utilized as the primary pre and post
device use objective parameters, and a quality of life
(QOL) instrument was utilized by all investigators.
Of specific interest, is that in the trial by Moore
[181]
181 one third of the women were identified as
having undergone previous vaginal surgery or colposuspension, and the three gynaecologists who fitted
the patients had no prior knowledge of how to fit the
device. Study periods varied from three to four
177 179],
179 12 weeks ([181]
181 and 6 months
weeks [177,
182
[182].
d) Recommendation
The development of a product for the external collection
of urine in the ambulatory and non-ambulatory female
patient is a very important area for future research.
GRADE OF RECOMMENDATION :D
There are currently no adequate collection devices
for the ambulatory female population.
2) Intravaginal devices which support the bladder
neck
a) Background
2. Three different single use disposable devices:
¥ a clam-type device composed of polyurethrane
foam, which is folded up upon its long axis and placed into the sagittal plane in the vagina, and when
moistened, its dimensions expand by 30% and create a supportive cushion under the urethrovesical
junction (Conveen Continence Guard, Coloplast,
Denmark) (Figure 9a, 9b) ([183],[184],[185]
184 185
183
¥ a newer version of the expanding polyurethrane
design, with similarities to a tampon, recently reported in an abstract (Coloplast, Denmark) (Figure 10)
[124],
124 and
Support of the bladder neck to correct urodynamic
stress incontinence has been achieved, with varying
success utilizing traditional i) tampons, ii) pessaries and
contraceptive diaphragms, and iii) intravaginal devices
specifically designed to support the bladder neck.
b) Quality of included studies
¥ Tampons/pessaries:
Nygaard[172]
172 performed a prospective, randomized,
single blind, and laboratory based study testing 18
patients (age 33-73) with three 40 minute standardized
aerobics sessions, utilizing either a Hodge pessary, a
super tampon, or no device and measuring urinary loss
by pad weight (PdWt).
¥ an expanding polyvinyl alcohol sponge (Ladycon,
124
Home Care Engros, Norway) [124]
607
FIgure 8 : Introl bladder neck support prosthesis
Figure 9 a : Conveen ÒclamÓ type devices with inserter
Figure 9 b: Conveen device (compressed by fingers) into
functional position assumed in vagina.
Figure 10 : Conveen ÒtamponÓ types within inserters.
608
Thyssen [184],
183 Hahn [185]
124
184 [183],
185 and Bidmead [124]
utilized PdWt and diary data as objective parameters
and employed QOL instruments. Of specific interest,
the abstract by Bidmead [124]
124 which reported a new
version of the device described as a continence ÒtamponÓ, utilized a crossover design, employing two five
week trials comparing the original and newer device.
The report on the polyvinyl sponge, by Glavind[186]
186
was an acute laboratory study of only six women utilizing a PdWt measurement during 30 minutes of aerobic
exercise.
C)
tiple vaginal surgeries or were oestrogen deficient.
Long-term follow-up showed that 18 of 26 (from the
original 65) continued to wear the device at six months
(interim dropouts being due to intercurrent illness in
half, the remainder had declining efficacy). Of these,
78% continued to wear the device for a minimum follow-up of two years. In a separate study of patients with
mixed incontinence by Moore [181],
181 of the 21 recruits,
five never wore the device home, leaving 16 participants. A further two did not reach week four, because of
poor efficacy or inability to fit the device. In the 14 who
reached week four, the median number of leaks/day
declined from 4.3 to 1.0 (p = 0.002). Median PdWt loss
fell from 53 to 7g (p = 0.012). Cystometry showed an
increase in maximum bladder capacity (p < 0.05) and a
modest reduction in severity of detrusor overactivity,
with no evidence of outflow obstruction. Three women
discontinued because of poor efficacy or a poorly fitting device, leaving 11 of 16 participants (69%) at week
eight, when median PdWt decreased to 2mL.
Results
¥ Tampons and Diaphragms:
Continence rates were 6/14 cured and 2/14 improved
172
with tampons [172],
4/10 improved with a diaphragm
173
[173],
and 9/12 with an oversized contraceptive diaphragm [174].
174
¥ Specific bladder neck support prostheses:
Due to significant differences in device design, the outcomes for the studies of the silastic device should not
be compared with the polyurethrane and polyvinyl
devices, which share similar modes of function. Of
note, all studies demonstrate an improvement in continence by the methods employed. Studies performed in
the acute setting, regardless of the device type, demonstrate better performance than diary based studies performed over time. Efficacy is also higher in patients
with minimal to moderate urinary leakage.
Kondo [182]
182 found no urinary flow obstruction with the
device in place. Urine loss decreased from 20.6 to 4.8
gm. per hour (p < 0.001) on the 60-minute PdWt. Twenty two patients (29%), reported complete continence,
and 39 (51%) had decreased severity of incontinence by
more than 50%. Minor adverse effects occurred in 26%
of the patients. According to the global usefulness
rating which was employed, 62 patients (81%) had
some or maximum benefit.
¥ Reusable intra-vaginal silastic device.
Thyssen [183],([42])
reported on 19/22 women with
183
42
stress incontinence, subjectively and objectively cured
or improved in a short-term study, and who then continued the treatment with the device for one year. All 19
completed the study, 13 (68%) were subjectively dry,
(26%) were improved and one (5%) reported unchanged incontinence. All but one had decreased leakage at
the 24-PdWt, and 67% a greater than 50% decrease.
Subjectively cure was 41%, and 36% were dry on 24
hour pad test. Overall reduced leakage was statistically
significant (p < 0.0005) No significant changes were
found in the other urodynamic measurements, specifically, urinary flow rate.
¥ Disposable polyurethane and polyvinyl devices:
Biswas [177]
177 determined that 86% of the patients were
continent with the device in place on cystogram.
Davila [179]
179 in the intial study demonstrated that (83%)
of patients were dry on PdWt. On further and more
detailed study, Davila found a statistically significant
reduction in incontinence on PdWt (USI, mean 46.6 to
16.6g; mixed incontinence, mean 31.9 to 6.8 g) and in
the bladder diary, mean 28.6 to 7.8 losses per week;
mixed incontinence, mean 30.2 to 15 losses per week).
QOL improved in both groups. Side effects included
five urinary tract infections and 23 cases of vaginal
mucosal soreness or mild irritation[178].
178
Hahn [185]
185 reported on 121 women, in a four week
study. Patients dropped out because of vaginal irritation
(25%), other product related reasons (6%), lack of time
(6%), or failure to complete a user questionnaire. Of the
remaining 90 (mean age 47.5), 85 performed a 24
PdWt, which showed that baseline leakage of 42 ml/
24h decreased to 14 ml/ 24h (p <0.001). Of these, 39
(46%) were continent. The device was considered
unpleasant by 8%, and caused some local discomfort in
62% on direct questioning: 75% of these wished to
continue using the device. The authors noted that older
women (age 56-65) tolerated the device and appeared
Moore[181]
181 detailed problems with both sizing and
efficacy. Of the 80 recruits, four could not be fitted, and
11 did not satisfy all entry criteria. Of the 65 participants, 39 (60%) withdrew; 20 for distorted vaginal anatomy which made fitting difficult, five for lack of efficacy, four for constipation, and ten for unrelated patient
events. In the remaining 26 patients, PdWt decreased
from a baseline median of 19 g to 2 g (p<0.001), 62%
were continent, and 15% were >50% improved, and
wished no further therapy. Moore concluded that the
device was difficult to fit in women who have had mul-
609
e) Recommendation
more motivated to continue. Coexistent atrophic vaginitis and the use of topical oestrogen was not discussed.
Vaginal support devices should be included in the treatment options when managing women with stress urinary incontinence, dependent upon the availability of product, patient acceptance, and cost and especially in
younger patients who may be contemplating further
pregnancies. However, long-term results are not available and studies comparing these therapies to other
forms of conservative therapy or surgery have not been
performed.
In the third study, by Thyssen [184]
184 subjective cure in
11/55 women (20%) and improvement in 27/55 (49%)
was reported. The 24-hour PdWt mean leakage and episodes in the voiding diary significantly decreased. After
three months, 55 (58%) of patients desired to continue
device usage. The IOQ showed highly significant
improvement, as well as two additional incontinence
related quality of life questionnaires. Responses to the
SF-36 general health questionnaire showed no significant changes.
GRADE OF RECOMMENDATION B
Bidmead[124]
124 reported on 61 women recruited in a
RCT , which compared the ÒclamÓ to the ÒtamponÓ
device. Only 38 (62%) completed the study due to discomfort or lack of efficacy. Thirty-six women desired
to continue device use following the study, with 73%
preferring the ÒtamponÓ type design for its ease of use.
Support of the bladder neck, resulting in improved
continence, is possible with intravaginal devices
without causing significant lower urinary tract obstruction or morbidity, but require patient acceptance
and a degree of manual dexterity for use.
d) Summary
3) Blockage of urinary leakage by occluding egress occlusive devices
Support of the bladder neck resulting in improved
continence is possible with intravaginal devices
without causing significant lower urinary tract obstruction or morbidity.
i) Blockage at the external meatus
a) Background
Devices have been developed which block urinary leakage at the external urethral meatus. Several devices
have utilised either adhesive or mild suction to occlude
urinary loss at the urethral meatus. In addition to a
simple barrier effect, compression of the wall of the distal urethra has been hypothesized to contribute to continence.
Efficacy with the Introl silastic pronged ÒpessaryÓ device ranged from 65-90% reduction in PdWt with 2983% dry and 15-50% improved [179],
182
178 [182],
179 [178],
[181],
At
six
months
32%,
and
at
two
years
22%
181 [180].
180
182 The major proof patients continued device use [182].
blem appears to be with sizing, especially in patients
with prior vaginal surgery or with vaginal atrophy
182 The device is re-usable so a fix cost following
[182].
purchase is to be expected. The device is not currently
marketed.
Efficacy with the Conveen polyurethrane expanding
ÒclamÓ device ranged from 20-68% of patients subjec184 There
185 [124]
124 and 49% improved [184].
tively dry [185],
was a 66% reduction in PdWt, with 46% of patients
continent. At one month 75% of patients [185]
185 and at
three months 58% [124]
124 continued device use, with
73% preferring the ÒtamponÓ type device. The device is
worn for 24 hours and is disposable. Difficulty with
insertion is improved with the ÒtamponÓ over the
ÒclamÓ version. The device is currently marketed
(Coloplast Ð www.coloplast.com). The polyvinyl tampon device was tested only in the laboratory during
186 It is currently marketed (Home
aerobic exercise [186].
Care Engros).
Patients must accept the mode of treatment and have
proper anatomy and manual dexterity. Relatively high
drop-out rates in monitored studies, during which
patient support is provided, indicates the need for proper patient selection and patient and provider education. (Level of Evidence = 2)
Miniguard (no current distributor) (Figure 11 ) is a triangularly shaped foam device which utilizes an adhesive hydrogel to adhere to the peri-meatal area. The device is single use, removed prior to voiding, and disposable.
FemAssist (no current distributor) (Figure 12 - FemAssist) is a hat-shaped silicone device, that adheres by
applying an adhesive gel to the edge of the device, squeezing the central dome and creating a vacuum. The device is then placed over the urethral meatus, and upon
release the meatal mucosa is drawn up into the device
and the urethral lumen is occluded. Designed and tested
in three sizes (3 x 2.5 cm, 2.5 x 2 cm 2 x 2 cm) it may be
worn for up to four hours or until voiding, after which the
device is washed in hot soapy water and then reapplied.
The device is reusable for one week.
CapSure (C. R. Bard, Inc but not currently marketed) is
applied and retained by suction. A petroleum based
lubricant is applied prior to device use. The device is
removed for voiding and re-utilized for up to 2 weeks.
b) Quality of included studies
Urinary diaries and PdWt were employed in all studies
610
for objective efficacy measurements [187]
187 (Minguard),
181 (FemAs189 (FemAssist), [181]
[188]
188 (Miniguard), [189]
190 191 (FemAssist), [192]
192 (CapSure).
sist), [190],[191]
Incontinence input questionnaires (IIQ), visual analogue score (VAS), QOL, and / or urogenital distress
188 [193],
inventory (UDI) were also employed [188],
193
189 [194],
190 [191],
192
[189],
191 [192].
194 [190],
Study lengths differed from laboratory [190],
four
190
194 to three months [188],
188 [191],
193 [189],
191
weeks [193],
189 [194]
[192].
192 There were no RCTÕs. Study designs were open
and longitudinal.
c) Results
¥ Miniguard
187 analyzed the efficacy of a single applicaEckford[187]
tion of this device during a one hour pad test which
reported that 25% of patients were continent, 50% were
improved, but 25% had worse incontinence. Brubaker
[188]
188 studied 648 recruited, 411 enrolled, 390 utilizing,
and 346 completing patients. Of the 65 women who did
not complete the trial, 21 withdrew before device use,
17 were lost to follow-up, 12 withdrew for device related reasons, nine developed an unrelated condition, and
there were six protocol violations. Brubaker reported
statistically significant objective (12 hour PdWt 15.8g
+/- 26.5 to 6.9g +/- 11.5 p<.001) and subjective (leakage questionnaire 10.1 +/- 5.1 to 3.5 +/- 4.3 p<.001 with
similar IOQ scores) improvement and no significant
change in urinary tract infections, postvoid residual
urine volume and cystometric indices. Symptoms of
vulvar irritation or lower urinary tract discomfort
occurred in a small percentage of subjects but were
generally transient, and only three women discontinued
using the device. The protocol employed a unique selfinstruction method by the patients. Also noted was a
persistence of efficacy (p<.001) 4 weeks following
device discontinuation.
Figure 11: Miniguard
¥ FemAssist
Versi [189]
189 reported that the mean pad weight decreased by 47% (P=0.056). Of the nine women who had a
positive pad test (>2 g) without the device, five were
dry (<2 g) with the device (P<0.05). VAS scores showed a significant improvement for the symptom of
stress incontinence (P<0.05). QOL scores improved
significantly by 38% (P<0.05) for the IIQ and and 29%
(P<0.01) for UDI. Versi [189]
189 studied 155 women with
stress or mixed leakage, of whom 133 attempted to use
it and 96 enrolled in a four week study. The mean pad
test loss fell from 27 g to 9.4 g (p< 0.001) and 49%
were dry. Cure was more likely in those with mild
incontinence.
Moore [181]
181 reported on 57/100 recruited women who
completed a one-month trial. Reduction of incontinence was statistically significant for pad testing, which
Figure 12: Fem Assist
611
revealed that 47% of the patients became continent and
33% had more than 50% benefit, while 9% had worse
leakage. Those with severe baseline leakage were
equally likely to respond as those with mild or moderate pad test loss. Women with stress, urge or mixed
incontinence appeared to respond equally well. Dropouts included 13% who were unwilling to utilize the
device [188].
188
selection based on motivation, appropriate anatomy,
and manual dexterity, in combination with efficacy and
morbidity will determine overall satisfaction. There is
no data which compares one extra-urethral device to
another, or to incontinence pads. A single RCT comparing extra-urethral and intra-urethral devices is reviewed in the section on intra-urethral devices (see below).
Cost comparisons for disposable versus short-term reusable devices are not available. Efficacy for different
grades of incontinence has not been established. The
objective degree of continence improvement in the clinical laboratory (pad and stress tests) is greater than in
community use (diaries). (Level of evidence = 3/4)
Tincello [190]
190 found the median (range) loss with and
without the device was 4.9 (0-65) ml and 21 (1-94), respectively (P< 0.01); and 20 patients were less wet when
using the device. The median (range) VAS scores were;
discomfort 35 (4-93), embarrassment 11 (0- 75), and
acceptability 65 (3-100). Discomfort was greater
among the women with a greater loss. The acceptability correlated negatively with discomfort (r = -0.53) and
negatively with embarrassment (r = 0.39); 15 patients
(56%) reported that they would use the device in the
long-term. Tincello [191]
191 reported that 10/41 women
(24.4%) declined to participate and six (14.6%) withdrew before two weeks. Ten (24.4%) failed to attend for
two-week follow-up and 11 (26.8%) did not continue
for three months. Two (4.9%) did not attend threemonth follow-up. Only two women (4.9%) completed
the study. There was no difference in pad test results or
in results from voiding diaries. The urinary incontinence device had low acceptability and was ineffective,
and we cannot recommend it for nonsurgical management of urodynamic stress incontinence.
¥ Capsure
e) Recommendation
Further research of the role of devices which block urinary leakage at the external urinary meatus are recommended. One half of patients utilizing these devices in
monitored studies were dry and 2/3 of the patients were
improved with minimal morbidity. These devices have
a role in the algorithm of conservative treatment based
on patient acceptance, availability and cost, especially
in those patients with mild or moderate stress incontinence who prefer to avoid pads or surgery. (Grade of
Recommendation C).
External patch in cup devices placed over the urethral
meatus, and held in place by an adhesive or mild suction have demonstrated efficacy with minimal morbidity.
ii) Intraurethral devices
Bellin [192]
192 reported on 88/100 completers after 12
weeks, with 82% elimination of leakage on Pad- Wt,
91% continent on provocative stress test (single cough
assessment of leakage), and 48 percent dry and 40%
improved on urinary diaries. Pad-Wt leakage decreased
from 6.67 gm (.55-25.95 range) to .19 gm (0-2.5 range)
by week 12. Five patients withdrew secondary to vaginal irritation and three due to poor device fit.
a) Background
Similarities among the devices which are inserted into
the urethra to prevent urinary leakage include a method
to prevent intravesical migration with a meatal plate,
enhance retention within the urethra, (by utilizing
spheres, dilations, inflatable balloons, or flanges), and
accomplish bladder emptying, by removal of the device. None of the devices are recommended for re-use
after removal. The FemSoft (Rochester Medical Corporation) (Figure 13) is currently distributed, but the Viva
and Reliance (Figure 14, 15) devices, which are also
reviewed in this sub-section, are not currently marketed.
d) Summary
External urethral occlusive devices were found to be of
varying efficacy, with minimal morbidity. Efficacy of
the combined studies reveals a continence rate of
approximately 50% dry and 2/3 of patients improved.
Of note, the studies by Tincello [190],[191]
191 suggested
190
poorer efficacy and patient satisfaction with the
FemAssist device, in distinction to other studies utilizing this device.
b) Quality of included studies
Neilsen [140],[195]
140
195 and Pechers [196]
196 studied patients
who utilized a disposable plastic device composed of an
oval meatal plate, a soft stalk with a removable semirigid guide, and spheres along the stalk (Viva). Peschers
screened 53 patients with USI and 21 patients accepted
treatment with the two sphere device. During a four
month study, the investigators analyzed subjective
improvement and performed pad-weight and cough
tests [196].
196
Adherence to the peri-meatal area is essential, as all
devices are occlusive, achieving the effect by either
blocking at the meatus or compressing the distal urethral lumen, as opposed to absorptive. However, the
method and degree of adherence is the determining factor for the type and severity of local irritation. Patient
612
Figure 13 : Femsoft Ð Urethral Insert
voiding (Reliance). Primary outcome included a laboratory PdWt-1hr. The patients reported on diary and
quality of life questionaires. Miller [198]
198 and Sand
[199]
199 reported on 63 of the 135 patients from the above
cohort who continued to utilize the balloon tipped intraurethral insert for one year.
Boos [200]
200 reported in an abstract, a randomized prospective parallel group trial comparing the Reliance
[197],
[198],
[199]
198
197
199 intra-urethral insert versus the
Femassist [193],
[189],
[194],
[190],
[191]
194
190
191 external
193
189
meatal occlusive device. Assessments at baseline, one
month, and three months included subjective efficacy,
seven day diary, and PdWt-1hr.
Figure 14 : Urethral plug
At the time of this report, results from a prospective
two-year follow-up study of the FemSoft urethral insert
are not yet available. In a small, randomized pilot study
assessing the efficacy of the FemSoft in preventing
incontinence during strenuous exercise, Dunn [201]
201
measured pad weights during four standardized aerobics sessions during which six subjects were randomly
assigned to exercise twice with the insert and twice
without it. The medians of the averaged pad weights for
the two different types of sessions were compared.
c) Results
Most patients who utilize intra-urethral devices report
dryness or improvement in the laboratory and on diaries. The major morbidities are discomfort, urinary tract
infections and hematuria. Most patients who completed
the studies were subjectively and objectively continent
or improved, Viva demonstrating 94.4% improvement
in leakage for Neilsen [195],
195 the ord 66.7% for Peschers [196].
196 The Reliance device provided 72% com-
Figure 15 : Reliance insert
Staskin [197]
197 reported on a four month study of 135 of
215 patients who utilized a disposable balloon tipped
urethral insert made from thermoplastic elastomer,
inflated with an applicator on insertion and deflated by
pulling a string at the meatal plate for removal during
613
plete dryness with 17% improvement on diary, and
80% complete dryness and 15% improvement on pad
weight testing for Staskin [197],
197 79% complete dryness
and 16% significant improvement on objective pad
weight studies consistent with the improvement in subjective diaries (p<.0001) for Miller [198].
198 The patients
reported improved comfort and ease of use over time,
with sensation of device presence decreasing from 35%
58
at week one to 7% at 12 months for ([58]).
The volume
of urine lost during exercise decreased from a median
of 20 gram (range 4.9-80.2 grams) without the insert to
2.6 grams (1.3-6.8) when the insert was worn (p=.03).
On a 5-point scale in which 1 represented very comfortable and 5 very uncomfortable, subjects rated the mean
comfort for the sessions performed with the insert in
place as 2.1.
undergoing screening urinalysis. Device migration into
the bladder, which requires endoscopic intervention for
removal, is the most serious reported problem. Long
term results are limited, although data on patients with
4 months to one year of intra-urethral device use do not
appear to demonstrate an increase in urinary loss by
objective testing, after device discontinuation [197],
197
[198],
198 [199].
199 Patient and physician acceptance of this
form of therapy has been limited, and the only device
reviewed in this section, which is currently commercially available is the FemSoft (Rochester Medical Corporation, 1800-FEMSOFT.com). (Level of Evidence: 3)
e) Recommendation
Further development and study of the use of intraurethral devices for the treatment of urodynamic stress
incontinence is recommended. The role of intraurethral
devices in patients who do not achieve the desired efficacy with other forms of conservative therapy, and wish
to avoid surgery, requires further study. The placement
of this therapy in the algorithm of conservative intervention has not been evaluated in relation to other
forms of conservative therapy and other devices (except
in one RCT abstract), with respect to short and long
term efficacy and safety, cost, and quality of life, and
comparative RCTÕs are needed.
Treatment for positive urine cultures was undertaken in
20% of symptomatic and 11% of asymptomatic
patients, 39% of patients had positive cultures which
were not treated and 30% had negative cultures at all
monthly intervals for the four month study. The main
reason for drop-out were discomfort [197].
One or
197
more episodes of gross hematuria (24%), cystoscopic
findings of mucosal irritation at 4 or at 12 months (9%)
and asymptomatic bacteruria (30%) on monthly cultures were also documented [198].
198
GRADE OF RECOMMENDATION: C
In the only comparative study, by Boos [200]
200 the superior efficacy of the intraurethral device (Reliance) versus
an extraurethral device (FemAssist) was mitigated by
the higher incidence of side effects. Of the 102 women
who were enrolled, 80 patients completed the study
with a reduction in incontinence, Reliance 28.6 cc (199) to 0.8 cc (0-4.6) 40.8% subjectively dry, and the
remainder improved, versus Femassist 36 cc (1.1-128)
to 4.3 cc (0-30) 28.3% subjectively dry, 60.4 % improved, 9.4% unchanged and 1 patient worse. Urinary tract
infections were seen in approximately 7% in both
groups at three months. The authors concluded that
both devices were efficacious, the Femassist being
more comfortable but requiring greater skill to achieve
continence, and the Reliance to be significantly better
in controlling incontinence but with a higher degree of
ÒnuisanceÓ side effects.
Intraurethral devices have demonstrated the highest
efficacy, but have been associated with higher incidence of urethral irritation, haematuria, and urinary
tract infection in comparison to other devices.
VI. GENERAL CONCLUSIONS &
SUMMARY OF
RECOMMENDATIONS
Conservative treatment (lifestyle interventions, physical therapies, bladder retraining and devices) should be
included in the counselling of incontinent women
regarding treatment options.
1. REGARDING LIFESTYLE INTERVENTIONS, stu-
d) Summary
dies to date have reported associations and only a
relatively small number of randomized trials have
been carried out to assess the effect of a specific lifestyle on incontinence. However, there is evidence
that:
Intraurethral inserts have demonstrated superior efficacy to other forms of devices used in the control of urinary incontinence [88].
88 The common morbidities associated with the use of these devices are urinary tract
infection, hematuria and discomfort. Bacteruria,
without symptomatic infection, was similar to extraurethral device use [88]
88 which approaches screening
urinalysis data [188],
188 or may be similar to the rates seen
with self catheterization [197].
197 Hematuria, microscopic
or gross, presents a diagnostic dilemma for a patient
- Obesity is an independent risk factor for the prevalence of urinary incontinence and weight loss would
appear to be an acceptable treatment option for morbidly obese women. At this time, there is scant information on whether weight loss resolves incontinence in women who are moderately obese.
614
- In view of the failure of most studies to separately
report self reported cure and improvement, it is difficult to estimate the size of the treatment effect.
However, it seems that improvement is a more common outcome than cure. In a meta-analysis of trials
comparing PFMT with no treatment, women in the
PFMT groups were 7.25 times more likely to report
cure than women in no treatment groups (RR7.25,
95% CI 1.99, 26.49) and this increased to 23.04
times for combined cure/improvement (RR23.04,
95% CI7.56, 70.22).
- Chronic straining may also be risk factor for the
development of urinary incontinence, however, there
have been no intervention trials that have examined
the effect of resolving constipation on incontinence.
- The data on caffeine intake and incontinence are
conflicting with a large cross sectional survey indicate no association, while smaller clinical trials have
suggested that decreasing caffeine intake improves
continence.
- The data relating to the association of smoking and
incontinence is conflicting. Smokers may have a different mechanism causing their incontinence than
non smokers. No data has been reported examining
whether smoking cessation resolves incontinence.
- Due to the lack of consistency in the trials evidence
of effectiveness of PFMT versus ES for (urodynamic) stress incontinence is not clear, although three
of the five trials show greater benefit of PFMT. On
the basis of the limited evidence currently available
there is no apparent difference in the effectiveness of
PFMT with or without biofeedback, or intravaginal
resistance devices, although clinicians may find
occasions when these would be useful adjuncts to
treatment for the purposes of teaching, motivation
and compliance.
- Strenuous exercise is likely to unmask the symptom
of stress incontinence during the provocation. There
is no evidence that strenuous exercise causes the
condition of incontinence. In a small number of
women without other known risk factors, extreme
provocation, such as parachute jumping, may cause
incontinence. There is scant uncontrolled data that
suggests that women engaged in occupations with
heavy lifting may be predisposed to genital prolapse
and/or incontinence. The data is, however, insufficient to draw any firm conclusions.
- There is insufficient evidence to determine whether
electrical stimulation (ES) is better than no treatment
for women with stress, mixed or urge incontinence.
- To date, the results of ES versus placebo ES in
women with urodynamic stress incontinence are
contradictory. There is a notable lack of consistency
in ES types and parameters used to treat incontinence in women with detrusor overactivity/overactivity.
There is a trend in favour of ES, but the trials are
small and not easily comparable.
- Apart from postural changes, there is no scientific
evidence about whether other lifestyle changes
affects either the treatment of or the prevention of
urinary incontinence.
2. REGARDING PHYSICAL THERAPIES
- There is Level 1 evidence to suggest that in women
with the range of urinary incontinence symptoms
(stress, mixed, urge), pelvic floor muscle training
(PFMT) is better than no treatment and should be
offered as therapy to women with those complaints.
For those women with mixed and urge incontinence,
it may be appropriate to offer PFMT in combination
with bladder retraining.
- For comparisons of ES with PFMT versus PFMT
alone, the reporting was very poor in three of the
four trials in women with stress incontinence, and
only a single trial was found for women with detrusor overactivity. At present, it seems that there is no
extra benefit in adding electrical stimulation to
PFMT.
- There is marked lack of consistency in PFMT programmes. On the basis of extrapolation from the
exercise science literature, PFMT protocols should
include 3 sets of 8 to 12 slow velocity maximal
contractions sustained for 6 to 8 seconds each, performed 3 to 4 times a week and continued for at least
15 to 20 weeks. Prior to PFMT, a person with skills
in the assessment and training of pelvic floor
muscles should assess each woman to ensure that a
correct voluntary pelvic floor muscle contraction is
being performed and to determine what facilitation,
techniques or adaptions, if any, are required to the
recommended training programme to ensure an
appropriate training intensity.
- The committee recommends that future trials of
electrical stimulation place particular emphasis on
identifying particular subgroups of the incontinent
population that are likely to benefit most.
- Treatment with vaginal cones may be better than
control treatment, however, it seems that it may be
no better or worse than ES or PFMT. The addition of
vaginal cones to a PFMT programme may add no
further benefit over PFMT alone.
- Many of the factors traditionally supposed to effect
the outcomes of physical therapy interventions (e.g.
severity of incontinence) maybe less crucial than
previously thought. The single factor that is consis-
615
tently associated with positive outcome is greater
motivation and/or compliance with the intervention.
At present, there is no convincing evidence of the
need for urodynamic evaluation to confirm diagnosis
prior to the initiation of physical therapies.
- Bladder retraining appears to have similar benefits
as drug therapy available prior to 1996 and may have
greater long term benefit. The additional benefit of
combining drug therapy with bladder retraining and
vice versa was not consistently noted and further
investigation is warranted.
- There is lack of evidence about the effectiveness of
PFMT or other PF rehabilitation programmes (e.g.
PFMT with electrical stimulation) for the prevention
of urinary incontinence.
- There is no convincing evidence of the need of urodynamic evaluation to confirm diagnosis prior to the
initiation of bladder retraining.
3. REGARDING BLADDER RETRAINING
4. REGARDING ANTI-INCONTINENCE DEVICES
- There is Level 1 evidence to suggest that for women
with urge, stress and mixed urinary incontinence,
bladder retraining is more effective than no treatment. Evidence is inconsistent about expected cure
rates, which maybe dependent on when and how the
outcome was measured or reflect differences in the
bladder retraining protocol.
- Although several classes of devices have demonstrated efficacy and tolerability in clinical studies, physician and patient acceptance have not been sufficient for commercial success. A lack of patient
acceptance has been associated with a lack of knowledge and comfort with genital anatomy, limited
manual dexterity in inserting and removing these
devices, physical discomfort, or cost. There are no
studies which characterize caregiver attitudes,
although a commitment to patient training may be a
barrier.
- There is a lack of consistency in bladder retraining
programmes. On the basis of extrapolation from the
bladder retraining literature, a retraining protocol
should include an initial voiding interval typically
beginning at 1 hour during waking hours only, which
is increased by 15-30 minutes per week depending
upon tolerance of the schedule until a 2-3 hour voiding interval is achieved. A shorter initial voiding
interval, i.e. 30 minutes or less, may be necessary for
women whose baseline voiding diaries reveal an
average voiding interval of less than 1 hour. Education should be provided about normal bladder
control and methods to control urgency such as distraction and relaxation techniques and pelvic floor
muscle contraction. Self-monitoring of voiding
behaviour using a voiding diary or treatment log
should be included in order to determine adherence
to the schedule, evaluate progress, and determine
whether the voiding interval should be changed. Clinicians should monitor progress, determine adjustments to the voiding interval, and provide positive
reinforcement to women undergoing bladder retraining at least weekly during the training period. If
there is no reduction in incontinent episodes after
three weeks of bladder retraining, the patient should
be re-evaluated and other treatment options considered.
- There are currently no adequate external collection
devices for the ambulatory female population.
- There are no RCTÕs on the utilization of pessaries for
urinary incontinence. Pessaries are the most commonly prescribed devices for vaginal prolapse, but
there are no studies to define those patients who will
respond, or those patients in whom support of the
prolapse will exacerbate urinary leakage.
- Bladder neck support prostheses, designed as a
modification of a pessary, as an intravaginal insert,
or as a modification of a tampon have shown efficacy in selected patients without significant prolapse
or a history of vaginal surgery, but require patient
acceptance and a degree of manual dexterity for use.
- External patch or cup devices, placed over the urethral meatus, and held in place by an adhesive or
mild suction have demonstrated efficacy with minimal morbidity.
- Intraurethral devices have demonstrated the highest
efficacy, but have been associated with higher incidence of urethral irritation, hematuria, and urinary
tract infection. Device migration into the bladder,
requiring cystoscopic removal, has also been reported.
- One RCT has indicated that bladder retraining and
pelvic floor muscle training have similar efficacy in
women with urge, stress and mixed incontinence and
this finding requires further investigation.
- Incontinence devices may be considered as an
adjunct to other forms of conservative therapy and
may be considered as an alternative to surgery, in
selected patients.
- The effectiveness of bladder retraining in combination with pelvic floor muscle training in comparison
to bladder retraining alone is unclear and further
investigation is also warranted.
616
treatment failures should be considered when evaluating efficacy, safety and satisfaction of outcomes.
Similarly, studies to determine the subgroups of
patients, who will derive the greatest benefit, should
be performed.
VII. RECOMMENDATIONS FOR
FUTURE RESEARCH
1. LIFESTYLE INTERVENTIONS
- Studies on the effectiveness of devices following
long term usage are needed. Long term data should
consider: a) the degree and persistence of efficacy, b)
the possibility of additional morbidity over time, c)
the persistence of benefit following device discontinuation, which may result from a training effect, and
d) the potential for loss of baseline function over
time, resulting from tissue damage or an anti-rehabilitative effect.
- Further research is needed to evaluate the effect of
several currently recommended lifestyle interventions on incontinence and whether their cessation
can alleviate or prevent this condition. These include: weight loss, heavy exertion/exercise, smoking,
caffeine intake, fluid intake, constipation on incontinence.
2. PHYSICAL THERAPIES
High quality RCTs with long term follow up are required to investigate:
- Device effectiveness and morbidity should be examined alone, in crossover studies with other devices,
and in combination with other therapies.
- the effectiveness of PFMT in comparison to other
interventions and to compare the effectiveness of
different PFMT programmes in the management of
urinary incontinence.
- Devices should be compared with other devices and
other interventions for efficacy, safety and cost
effectiveness.
- the effectiveness of PFMT with other adjuncts in
comparison to PFMT alone and effectiveness of different biofeedback protocols.
APPENDIX 1
- all aspects of the use of electrical stimulation in the
treatment of urinary incontinence.
1. SEARCH STRATEGIES
a) Lifestyle Interventions
- the effectiveness of physical therapies to prevent
incontinence in women at risk or in the general
female population.
Reports on lifestyle interventions were obtained by
searching MEDLINE (languages English, Scandinavian, German) from 1976 to December 2000 using the
following keywords which were linked to urinary
incontinence: lifestyle interventions, weight, obesity,
weight loss, exercise, work, physical activity, smoking,
tobacco, coffee, caffeine, posture, constipation, bowel
function, fluids, fluid restriction, timed voiding, clothing, pulmonary status, cough, and diet.
- the subgroups of patients who would derive the greatest benefit from physical therapies.
3. BLADDER RETRAINING
- High quality RCTs with long term follow up are
required to compare bladder retraining alone and in
combination with lifestyle interventions, physical
therapies and drug therapies in the management of
stress, urge and mixed incontinence.
Anecdotal recommendations made in the literature
unaccompanied by data of any sort are not reported.
b) Physical Therapies
- Research is needed to determine the subgroups of
patients who will derive the greatest benefit from
bladder retraining along or in combination with physical therapies or drug therapy and also to determine
the long term efficacy of bladder retraining.
¥ Systematic reviews
Reports of systematic reviews evaluating the effectiveness of physical therapies for prevention and treatment
of female stress, urge and mixed incontinence were
obtained by searching MEDLINE, EMBASE,
CINAHL and The Cochrane Library. Key search terms
were systematic review, meta-analysis, and incontinence. The date of the most recent search was November
2000. In addition the authors of this section on physical
therapies had contributed to Cochrane systematic
reviews of physical therapies for incontinence that were
in press at the time of writing this chapter. The evidence from both these reviews (pelvic floor muscle training
4. DEVICES
- High quality RCTÕs with long term follow up are
needed. However, it is acknowledged that device
protocols may not easily employ a non-treatment
group, cannot easily employ a ÔplaceboÕ model, and
are usually designed as open longitudinal studies,
utilizing the patientsÕ baseline data as the control.
Specifically within the field of device investigation,
intention to treat and the inclusion of dropouts as
617
se the patient as their own control and derive outcome
data based on change from baseline. There is only one
abstract which compares one device to another. Two
abstracts have been included, based on the use of comparative data and are noted as such in the references and
text.
for female urinary incontinence, physical therapies for
prevention of incontinence) was therefore available for
inclusion.
¥ Electrical stimulation
The Trials Search Co-ordinator of the Cochrane Incontinence Group obtained reports of RCTs evaluating the
effect of electrical stimulation for stress, urge and
mixed incontinence from a search of the Specialised
Trials Register of the Cochrane Incontinence Group.
The Register contains trials identified from MEDLINE,
CINAHL, The Cochrane Controlled Trials Register and
handsearching of journals and conference proceedings.
The date of the last search was November 2000.
2. ACKNOWLEDGEMENTS
We would like to acknowledge the secretarial assistance of Maria Treloar and Christine Cooper in the coordination and preparation of this Chapter.
REFERENCES
c) Bladder Retraining
Reports of bladder retraining were obtained by searching MEDLINE and CINAHL from February 1966 to
December 2000 using the following keywords which
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Bladder Training for Urinary Incontinence in Adults
([149]Roe
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149
Database of Systematic Reviews and those from review
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146 147 [148]
148 and retrieved manuscripts
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6
2. Types of participants: noninstitutionalized women
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Thom, D.H., Van Den Eeden, S.K. And Brown, J.S. Evaluation
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14
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To be considered for inclusion, studies had to meet the
following criteria:
3. Type of intervention: Bladder retraining used in the
management of urinary incontinence
4. Publication type: full published reports in English
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adopted from the standard usage, such as contraceptive
diaphragms or pessaries, are reported in the subsection
which is consistent with their presumed mode of action.
Prospective trials of devices have generally not been
randomised or parallel controlled, as these studies utili-
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Jšrgensen, S., Hein, H.O. And Gyntelberg, F. Heavy lifting at
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(44): 47-49, 1994.
B¿, K., Stein, R., Kulseng-Hanssen, S. And Kristofferson, M.
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women with and without stress incontinence symptoms: a casecontrol study. Obstetrics and gynecology. 84 (6): 1028-1032,
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B¿, K., M¾hlum, S., Oseid, S. And Larsen, S. Prevalence of
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Nygaard, I.E. Does prolonged high-impact activity contribute
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Bump, R.C. And McClish, D.M. Cigarette smoking and pure
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