1. No category

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Scandinavian Journal of Urology and Nephrology
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Evaluation of health-related quality of life in patients with painful bladder
syndrome/interstitial cystitis and the impact of four treatments on it
Jukka Sairanen a; Mikael Leppilahti b; Teuvo L. J. Tammela c; Ilkka Paananen d; Sirpa Aaltomaa e; Kimmo
Taari a; Mirja Ruutu a
a
Department of Urology, Helsinki University Hospital, Helsinki, Finland b Division of Urology, Seinäjoki Central
Hospital, Seinäjoki, Finland c Department of Surgery/Urology, Tampere University Hospital, and Medical
School, Tampere, Finland d Department of Urology, Oulu University Hospital, Oulu, Finland e Department of
Urology, Kuopio University Hospital, Kuopio, Finland
First Published on: 09 January 2009
To cite this Article Sairanen, Jukka, Leppilahti, Mikael, Tammela, Teuvo L. J., Paananen, Ilkka, Aaltomaa, Sirpa, Taari, Kimmo and
Ruutu, Mirja(2009)'Evaluation of health-related quality of life in patients with painful bladder syndrome/interstitial cystitis and the
impact of four treatments on it',Scandinavian Journal of Urology and Nephrology,
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Scandinavian Journal of Urology and Nephrology
2009, 18, iFirst article
ORIGINAL ARTICLE
Downloaded By: [Consorci de Biblioteques Universitaries de Catalunya] At: 10:07 27 February 2009
Evaluation of health-related quality of life in patients with painful
bladder syndrome/interstitial cystitis and the impact of four treatments
on it
JUKKA SAIRANEN1, MIKAEL LEPPILAHTI2, TEUVO L. J. TAMMELA3,
ILKKA PAANANEN4, SIRPA AALTOMAA5, KIMMO TAARI1 & MIRJA RUUTU1
1
Department of Urology, Helsinki University Hospital, Helsinki, Finland, 2Division of Urology, Seinä joki Central Hospital,
Seinä joki, Finland, 3Department of Surgery/Urology, Tampere University Hospital, and Medical School, Tampere, Finland,
4
Department of Urology, Oulu University Hospital, Oulu, Finland, 5Department of Urology, Kuopio University Hospital,
Kuopio, Finland
Abstract
Objective. Painful bladder syndrome/interstitial cystitis (PBS/IC) is an inflammatory bladder disease of unknown origin.
Symptoms of PBS/IC compromise patients’ quality of life (QoL). This study evaluated a health-related quality of life
(HRQoL) questionnaire in PBS/IC. Material and methods. 151 patients with PBS/IC filled in the HRQoL questionnaire
before and after the treatment. Of these, 87 patients participated in a 3-month randomized study testing intravesical
dimethyl sulfoxide (DMSO) and bacille CalmetteGuérin (BCG) and 64 patients took part in a 6-month randomized study
evaluating oral cyclosporine A (CyA) and pentosan polysulfate sodium (PPS). The changes in HRQoL questionnaire were
evaluated with respect to the changes in global response assessment (GRA). Results. The results of the HRQoL
questionnaire reflected well the post-treatment GRA. Patients responding to their treatment had improved QoL. CyA
treatment had more impact on emotional well-being, social functioning, activity limitation days, pain and physical capacity
than PPS treatment (pB0.05). More patients responded to DMSO than BCG treatment according to GRA (pB0.01), but
the results in HRQoL questionnaire were equal after DMSO and BCG treatments. Conclusions. The HRQoL questionnaire
can be used in evaluating QoL in PBS/IC patients. Treatment of PBS/IC had obvious effects on QoL.
Introduction
Painful bladder syndrome/interstitial cystitis (PBS/
IC) is a debilitating bladder disease of unknown
origin. The symptoms include bladder-related pain
and urinary frequency in the day-time and nighttime. Treatment options have an unforeseeable effect
on the symptoms as the aetiology remains elusive.
Dimethyl sulfoxide (DMSO) and pentosan polysulfate sodium (PPS) therapies have shown to be
superior to placebo, and the Food and Drug
Administration (FDA) has approved only these two
treatment options for PBS/IC [13]. Other treatments with reported promising results include intravesical bacille CalmetteGuérin (BCG) and oral
cyclosporine A (CyA) [4,5].
Quality of life (QoL) of PBS/IC patients is
compromised owing to the chronic state of the
disease. It was shown in an Austrian health screening
project that the prevalence of PBS/IC-related symptoms affected QoL in women who participated in the
survey [6]. It is advisable, when conducting an
interventional study on PBS/IC, to include an
evaluation of QoL [7]. No specific questionnaire
exists for PBS/IC for such studies. A single QoL
question appears in some studies [8], and more
comprehensive questionnaires like SF-36 have
served in some other studies [911]. General questionnaires can evaluate different QoL aspects. Such a
questionnaire should be simple enough to be incorporated in an outpatient clinic-based follow-up
study. For example, the questions should be relevant
Correspondence: J. Sairanen, Urologian klinikka, 1. kerros, PL 340, FI-00029 HUS, Finland. Tel: 35 8504271039. Fax: 35 8947178392. E-mail: jukka.
[email protected]
(Received 9 July 2008; accepted 8 December 2008)
ISSN 0036-5599 print/ISSN 1651-2065 online # 2009 Informa UK Ltd. (Informa Healthcare, Taylor & Francis AS)
DOI: 10.1080/00365590802671031
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2
J. Sairanen et al.
to patients, easy to understand and quick to answer.
A comparative trial with four generic QoL instruments showed that none of those could be considered as the gold standard [12]. Authors suggested
that researchers should select an instrument sensitive
to the health states they are investigating.
In 1995, Cleary et al. introduced a questionnaire
to measure whether the effect of antiandrogen
therapy differs from that of castration on the QoL
in patients with prostate carcinoma (PC)[13]. This
was tailored to be easy to answer; it covered domains
of general health perceptions, pain, emotional wellbeing, vitality, social functioning, physical capacity,
sexual interest, sexual functioning, activity limitation
and bed disability. The questions in single domains
were mainly adapted from QoL questionnaires
previously established and validated. This HRQoL
questionnaire was further translated and validated in
several languages and proved effective in a cohort of
550 patients with PC. As it is also available in
Finnish and Swedish, the two official languages in
Finland, it was adapted for the present clinical PBS/
IC trials.
A common endpoint in intervention studies is
global response assessment (GRA) [14]. GRA classifications differ. On a six-point scale one category is
for symptom deterioration and one for stable disease, whereas four are for symptom improvement.
This study aimed to find out whether the change
in HRQoL questionnaire correlates with the GRA.
Two prospective, randomized, open-label, intervention studies on PBS/IC were conducted. In the first
study, intravesical DMSO was compared with intravesical BCG. In the second study, the clinical
effect of oral cyclosporine A (CyA) was compared
with pentosan polysulfate sodium (PPS). In these
two separate trials the usefulness of the HRQoL
questionnaire was assessed by comparing its change
with a GRA given by the patient. Further, the study
investigated whether intravesical DMSO or BCG
and oral CyA or PPS have different impacts on
HRQoL.
Material and methods
Two consecutive clinical studies on the treatment of
PBS/IC were carried out as multicentre studies in
eight urological units in Finland. The first study
comprised 75 patients with PBS/IC recruited from
September 1999 to June 2002. The patients were
randomized in a 1:1 ratio to six weekly instillations
with either 50 ml 50% DMSO or 50 ml Tice strain
BCG.
The endoscopic appearance of the bladder after
the last hydrodistension was similar in the DMSO
and BCG groups. In the DMSO group 16 patients
had extensive glomerulations, nine had moderate
glomerulations and 12 had only light glomerulations.
In the BGC group there were 21 extensive glomerulations, eight moderate glomerulations and nine
light glomerulations.
Five patients in the CyA group and 10 in the PPS
group had a Hunner’s ulcer; these numbers do not
differ statistically.
All patients filled in the HRQoL questionnaire
before treatment and in the follow-up at 3 months.
They also marked in the follow-up their subjective
global assessment of treatment response (GRA).
GRA was graded as follows: 1 worse, 2no
change, 3 slightly better, 4 moderately better,
5much better, and 6 completely cured. Participants who reported either of the two latter categories
were considered treatment responders. At 3 months,
if treatment response was not achieved, the patients
were allowed to change to another treatment group
without any specified washout period. Then a new
baseline HRQoL questionnaire and a new outcome
questionnaire at 3 months were obtained.
The second study randomized 64 patients to
either oral CyA (1.5 mg/kg twice a day) or oral
PPS (100 mg three times a day). The same questionnaire was filled in by the patients before and after
6 months of treatment. GRA was analysed by the
same method as described above. This study started
randomizing patients in October 2002 and stopped
in March 2004. The clinical results of that study
were published in detail [15]. The patients who
dropped out from their treatment before the study
end were considered non-responders (GRA 1). Inclusion and exclusion criteria for patient selection for
both studies depended on the National Institute of
Diabetes and Digestive and Kidney Diseases
(NIDDK) criteria for PBS/IC [16]. During the study
period, no other specific treatment for PBS/IC was
given and the effect of any previous treatment (e.g.
hydrodistension) had to have disappeared. No specific time limit was given to wait before starting
DMSO, BCG, CyA or PPS treatment after a failed
previous therapy. Analgesics or medication for insomnia were still allowed when necessary. The utility
of the QoL questionnaire was assessed by comparing
it with the subjective GRA. The changes in different
categories of QoL were calculated according to
treatment group.
Quality of life questionnaire
A 30-item questionnaire (Appendix) was selected.
This previously validated questionnaire was available
in Finnish and Swedish. It comprises different
fields of QoL: general health perceptions, pain,
emotional well-being, vitality, social functioning,
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Quality of life with painful bladder/interstitial cystitis
physical capacity, and both sexual interest and
functioning. Questions about disability days and
activity limitation days are also included. A question
addressing the issue of erectile dysfunction was left
out because 89% of the patients were females.
Statistical analysis was done with SPSS 13.0. The
Wilcoxon rank sum test was used to compare QoL
points between different GRA categories. One-way
ANOVA was applied to calculate the similarity of
baseline characteristics between all treatment arms.
Differences in the response rates between the treatments were calculated by Fisher’s exact test. The
t test was used in comparison of treatment efficacy in
the different domains of QoL.
For both studies the sample size was calculated on
a specific power analysis which was based on the
improvement of clinical symptoms. In the CyA/PPS
study a sample size of 64 was selected to detect a
difference in response rates of 70% and 35%, and
80% power at a two-sided significance level of 5%
was used. Loss of 10% of patients in the follow-up
was estimated. In DMSO/BCG study the primary
endpoint was alleviation of pain, as a visual analogue
scale (VAS) score. A 50% reduction in pain on the
VAS was calculated to be seen in 40% of patients in
the DMSO group and 65% of patients in the BCG
group. Power of 80% at a two-sided significance level
of 5% was used. Patient loss in follow-up was
estimated to be 20%, which raised the total number
of patients needed to 72.
All patients gave written informed consent. The
study protocols were approved by the ethics committees of all participating hospitals.
Results
In the first study 37 patients were randomized to
DMSO treatment and 38 to BCG treatment. Thirteen patients in the BCG group changed into the
DMSO group at 3 months and 12 patients in
the DMSO group changed into the BCG group.
The total number of treatments with either instillation was 100 (50 in each group). Six patients in the
DMSO group and seven in the BCG group dropped
out before the 3 month final evaluation, leaving 87
treatments for analysis. In the second study, 29
patients out of 32 in both CyA and PPS groups
completed the study, leaving 58 patients for final
analysis.
The patients’ baseline characteristics and number
of responders to treatment are listed in Table I. The
patients in the CyA/PPS study had smaller bladder
capacities than in the DMSO-BCG study, resulting in
more frequent voiding in 24 h. There was a higher
response rate after DMSO therapy than after
BCG therapy (p B0.01), and CyA therapy had a
3
significantly higher response rate than PPS therapy
(p B0.001). In the whole cohort, when only the
primary instillation therapy is included, 38 patients
(27%) responded to the therapy (GRA 5 or 6),
whereas 101 (73%) did not (GRA 14). When the
secondary instillation (after group change) was also
included, the number of treatment responders increased to 50 (32%) (Table II).
Of the 164 HRQoL questionnaires distributed at
the beginning, 158 were obtained before treatment
(six patients did not return the questionnaire). After
treatment 138 questionnaires were evaluated. There
were 20 forms missing at follow-up, owing to 19
dropouts during the treatment and one form being
lost. The questionnaire was usually answered conscientiously, but the questions concerning sexuality
were left unanswered by half of the patients. Sixtyseven patients out of 164 (41%) reported having had
sexual activity within the past month. There were no
differences in sexual activity between the four treatment groups.
Post-treatment GRA correlated with the change in
HRQoL questionnaire (Table II). If the patient
responded to the treatment (GRA 5 or 6), the
HRQoL questionnaire improved significantly in
aspects of general health perceptions, pain, emotional well-being, vitality, social functioning and
physical capacity. Disability days and activity limitations days were also significantly changed in those
patients. The domain of pain was improved also in
patients in GRA 4 category. Furthermore, patients
with impaired symptoms after treatment (GRA 1)
experienced worse HRQoL in social functioning and
had more disability days (Table II).
HRQoL was statistically similar in all four treatment arms at baseline. DMSO and BCG therapies
had an equal effect on HRQoL, but CyA therapy
resulted in significant changes in HRQoL compared
with PPS. The results are shown in Figure 1.
Discussion
This study showed a correlation between GRA and a
common HRQoL questionnaire. The results indicate that patients having either GRA 5 or 6 (much
improved or cured) after treatment also have improved QoL. They are the true treatment responders.
No previous reports testing the effect of intravesical DMSO, oral PPS or CyA therapy on QoL in
patients with PBS/IC exist to be used as a reference
or comparison to the present study.
In this study the response rate was higher after
CyA therapy than after PPS therapy. CyA also had a
significant impact on the HRQoL questionnaire.
The superiority of CyA to PPS in the HRQoL
4
J. Sairanen et al.
Table I. Baseline characteristics of the patients and the response rates in the treatment groups.
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Female/male
Age of the patients
Duration of symptoms (years)
Frequency in 24 h
Nocturia episodes
Mean voided volume (ml)
VAS (cm)
No. of treatment responders (%)
(GRA 5 or 6)
DMSO
(n37)
BCG
(n38)
CyA
(n 32)
PPS
(n 32)
Total
(n 139)
Difference between all
study arms (one-way
ANOVA)
37/0
61.4911.3
11.3910.1
14.295.7
4.092.5
147958
6.492.1
11 (30%)
34/4
57.9914.7
8.598.5
14.296.1
4.192.6
140963
6.892.1
4 (11%)
27/5
56.2914.7
7.897.0
16.794.4
3.992.2
122939
6.892.0
19 (59%)
26/6
59.7913.3
8.996.7
19.198.4
4.293.3
106946
7.092.1
4 (13%)
124/15
59.2913.0
9.798.7
15.596.17
4.092.6
136958
6.792.0
38 (27%)
NS
NS
NS
p 0.002
NS
p 0.002
NS
+
Data are shown as mean9SD.
Baseline characteristics compared between dimethyl sulfoxide (DMSO) and bacille CalmetteGuérin (BCG) groups or between
cyclosporine A (CyA) and pentosan polysulfate sodium (PPS) groups were similar.
VASvisual analogue scale; GRAglobal response assessment; NS not significant.
*The response rate was higher in the DMSO group than in the BCG group (p B0.05) and in the CyA group than in the PPS group
(p B0.001) (Fisher’s exact test).
questionnaire is in accord with a previous report of
its clinical effects on PBS/IC-related symptoms [15].
Both BCG and DMSO treatments had a similar
impact on the HRQoL questionnaire. However, it is
not possible to compare the HRQoL results directly
between the two study groups (DMSO/BCG versus
CyA/PPS) because these were two independent
studies with different treatment protocols. Although
the inclusion and exclusion criteria were similar in
both protocols the patients had smaller mean voided
volumes and higher frequency in 24 h in the CyA/
PPS study. There were no differences between the
groups regarding patients’ age, gender distribution,
mean symptomatic time before the studies, VAS
score for pain or numbers of nocturia episodes. Most
important was that there were no differences in any
aspects of baseline results in the HRQoL questionnaire, making it possible to use that as an endpoint.
In that respect, it is suitable to report the changes in
HRQoL in different GRA categories of the whole
cohort, but head-to-head comparison of treatment
effect with voiding symptoms or symptom scores is
Table II. Results of the health-related quality of life questionnaires after treatment with any of the four therapies according to the global
response assessment (GRA) (1worse, 2no change, 3 slightly better, 4moderately better, 5much better, 6 completely cured).
Measure
Baseline
(n158)
GRA 1
(n11)
GRA 2
(n 27)
GRA 3
(n27)
GRA 4
(n 23)
GRA 5
(n34)
GRA 6
(n 16)
General health perceptions (010)
5.291.9
4.291.9
5.092.6
5.391.9
5.792.0
Pain (110)
5.491.8
6.192.2
5.992.2
4.092.2
Emotional well-being (0100)
62.0918.0
50.4914.4
59.7917.1
62.5915.1
3.791.4
p 0.007*
72.7914.7
Vitality (0100)
55.0916.7
48.5912.8
55.3918.0
55.5916.0
65.1917.7
Social functioning (16)
3.291.3
3.391.5
3.791.4
4.091.5
Physical capacity (1 best5 worst)
2.190.7
2.191.2
p0.03$
2.791.0
2.090.9
1.990.9
1.790.7
7.392.2
p 0.011*
1.891.5
p 0.002*
81.5913.5
p 0.026*
75.1914.1
p 0.029*
5.491.0
p 0.002*
1.691.0
Sexual interest (15)
Sexual functioning (15)
Disability days (07)
1.790.8
2.591.3
1.191.7
1.790.8
3.191.6
1.291.4
1.990.8
2.090.7
0.490.9
1.790.9
2.791.3
0.591.0
Activity limitation days (07)
3.392.2
3.392.1
2.592.5
2.291.9
6.792.1
p0.001*
2.591.4
p0.001*
79.8916.2
p 0.01*
68.1914.9
p0.014*
5.091.1
p0.001*
1.490.5
p0.002*
1.890.8
2.791.1
0.290.6
p0.035*
1.091.4
p0.001*
1.590.7
3.391.6
2.191.9
p 0.026$
4.392.0
2.191.1
1.690.7
0.691.8
0.390.7
p 0.01*
Data are shown as mean9SD.
Patients having a secondary treatment with either dimethyl sulfoxide (DMSO) or bacille CalmetteGuérin (BCG) are included.
$
Significant difference compared with baseline towards impairment; *significant difference compared with baseline towards improvement.
Wilcoxon Rank Sum test used in all measurements.
DMSO
BCG
CYA
PPS
BCG
CYA
PPS
5.8±1.6
4.9±2.3
2.9±2.1
5.5±1.7
5.31.9
4.2±2.5
3.1±1.3
3.4±1.4
5.0±1.3
3.3±1.1
3.8±1.6
1.1±1.7
CYA
PPS
CYA
0.8±1.5
0.5±0.8
0.5±1.1
1.2±1.3
0.9±1.5
BCG
PPS
BCG
CYA
PPS
DMSO
BCG
CYA
16 (50%)
16 (55%)
15 (52%)
11 (34%)
2.7±1.4
2.9±1.3
2.3±1.2
2.7±1.0
2.4±1.2
2.5±1.5
2.7±1.4
DMSO
18 (42%)
(k)
2.0±1.0
1.6±0.6
1.8±0.8
2.0±1.0
2.2±1.0
1.7±0.9
1.7±0.9
1.6±0.8
1.6±0.8
DMSO
5.2±1.9
DMSO
(j)
(i)
BCG
0.7±1.5
0.8±1.5
0.5±0.8
1.2±1.3
0.5±1.1
1.1±1.7
0.9±1.5
1.3±1.9
PPS
PPS
(h)
0.7±1.5
1.9±0.7
1.7±0.7
2.2±0.5
CYA
DMSO
22 (44%)
BCG
1.5±0.7
2.0±1.1
2.1±0.8
2.1±0.8
DMSO
4.2±1.6
53.8±16
PPS
1.3±1.9
CYA
60±16
63.9±16
50.3±12
58.0±21
65.2±16
56.7±19
BCG
(g)
1.8±0.8
(f)
DMSO
19 (43%)
PPS
CYA
(e)
57.0±17
65.4±15
58.8±18
58.5±13
CYA
BCG
18 (36%)
BCG
75.9±15
65.5±20
65.4±21
70.6±18
DMSO
DMSO
3.2±1.3
5.4±1.9
PPS
3.2±1.5
CYA
5.9±2.0
5.2±1.7
6.4±2.2
5.2±2.0
BCG
(d)
63.70±19
(c)
5.4±2.7
5.2±1.9
5.9±2.2
DMSO
3.1±2.0
(b)
(a)
PPS
Figure 1. Results of the HRQoL questionnaire after four treatments: dimethyl sulfoxide (DMSO), bacille CalmetteGuérin (BCG), cyclosporine A (CyA) and pentosan polysulfate sodium (PPS).
The patients receiving DMSO or BCG as a secondary instillation are also included. Results are presented as mean9SD. Baseline results in the HRQoL questionnaire were comparable between all
groups (one-way ANOVA). Number of patients included: DMSO 50 pretreatment and 44 post-treatment, BCG 50 pretreatment and 43 post-treatment, CYA 32 pretreatment and 29 posttreatment, PPS 32 pretreatment and 29 post-treatment. Black bars pretreatment values; white bars post-treatment values. (a) general health perceptions 010; (b) pain 110; (c) emotional wellbeing 0100; (d) vitality 0100; (e) social functioning 16; (f) physical capacity 15 (1 best, 5 worst); (g) disability days 07; (h) activity limitation days 07; (i) sexual interest 15 (1 best, 5 worst);
(j) sexual functioning 15 (1 best, 5 worst); (k) number of patients (%) having sex (masturbation or intercourse). The effect of DMSO and BCG treatments on all aspects of the HRQoL did not
differ from each other. The effect of CyA was greater than that of PPS on aspects of pain, emotional well-being, social functioning, physical capacity and activity limitation days (pB0.05; t test).
Quality of life with painful bladder/interstitial cystitis
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J. Sairanen et al.
possible only between DMSO and BCG, and
between CyA and PPS. The treatments were not
blinded in the CYA/PPS study because of the safety
measurements in the CyA group and the different
daily dosing intervals of the drugs. In the DMSO/
BCG study the patients were allowed to switch the
treatment arms if they had no response to their
treatment.
The HRQoL questionnaire implemented in this
study has never been used in PBS/IC before. It has
been used in studies with prostate cancer under
hormonal treatment [13,17,18]. The authors think
that it is comparable to any other standard validated
HRQoL questionnaire. Boccardo et al. [17] adopted
the questionnaire for the follow-up of patients with
bicalutamide monotherapy or total androgen blockade in the treatment of PC, but did not use the
original method of calculating the points in different
domains. The present study followed the original
method of reading the results [13].
The prognosis of PBS/IC and PC is different and
the gender distribution between the participants
(93% of this PBS/IC cohort being female) was
almost opposite. Head-to-head comparison of the
results in the HRQoL questionnaire between PBS/
IC and PC is impossible. Still, some comparison can
be made between these results and those of Clearly
et al. [13], to recognize the impact of PBS/IC on
QoL.
The pain differed a lot between these populations,
as PBS/IC patients had more pain than PC patients.
In the Cleary study [13], the pain index (mean9SD)
was 3.292.1 for the 487 PC patients under hormonal therapy, while it was 5.491.8 for the present 139
patients before starting the therapies. The pain index
for the present cohort reduced to a mean of 3.892.3
after the therapies, which was still higher than that of
patients with PC under hormonal therapy. These
results can be considered as expected as PBS/IC is a
syndrome with the most important symptom being
pain [19,20]. Other impaired domains in PBS/IC
patients were emotional well-being, social functioning and general health perceptions compared with
PC patients in the study by Cleary et al.
The HRQoL questionnaire used here was practical, easy to fill in and well received by the patients.
The questions on sexuality were an exception, with a
low response rate. This may be explained by the low
sexual activity in the cohort and by the domain not
being seen as important. The measures of sexual
interest and functioning also worked poorly in the
development procedure of this questionnaire [13].
The questions considering sexuality should be revised and asked separately, when that domain is of
particular interest. In patients younger than these
(mean age 59.2 years in this cohort) sexuality is an
important issue. In this study only 40% of patients
were sexually active. In a previous study, sexual
function was proposed to be an important predictor
of physical QoL [21]. However, that study also
suffered, probably because of embarrassment, from
lacking answers considering sexuality. Forty-nine per
cent of women with PBS/IC reported difficulties in
sexual intercourse due to exacerbation of their
bladder symptoms [22], and fear of provoking the
PBS/IC symptoms by sexual intercourse is reported
to be significant [23]. In the present study, sexual
activity did not increase in patients having a good
treatment response. That may be due to neglecting
the questions concerning sexuality, or it may reflect
permanent low sexual activity among the cohort.
After successful therapy, assessed subjectively, the
QoL is improved. The sensitivity of the HRQoL
questionnaire to identify treatment failures was
interesting. Social functioning (p 0.03) and disability days (p 0.026) showed significant impairment in patients in GRA 1 category, in whom the
symptoms became worse after treatment. The ability
of a questionnaire to detect negative changes in QoL
makes it a more reliable tool.
Of the treatments in this study, only the effects of
BCG therapy on QoL have been reported previously.
In a cohort with eight patients, QoL (assessed by the
Rand-36 questionnaire) improved after open-label
BCG therapy by a mean of 64% [24]. This remarkable change may be explained by the reported results
that all patients were treatment responders to BCG.
In a placebo-controlled trial BCG had more positive
impact on social function and fatigue than placebo,
but not on any other Rand-36 domain [4]. In the
latest clinical studies the effect of BCG therapy on
PBS/IC has been somewhat disappointing, arguing
against its the routine use [25].
Despite the HRQoL questionnaire used in this
study proving effective in showing differences in
treatment outcome in both improved and impaired
GRA categories, the development of a questionnaire
with additional questions regarding PBS/IC-related
problems is still needed. Women and men could
even have their own questionnaires as gender has a
recognizable impact on the coping strategies to
different diseases and on the outcome of treatments
[2628]. In the future, a validated questionnaire
should be internationally available for large-scale
prospective studies. In Europe, the designing of such
a questionnaire is possible, as the active European
Society for the Study of IC/PBS (ESSIC) has
demonstrated its productivity by proposing new
diagnostic criteria and nomenclature on PBS/IC
[29].
In conclusion, treatment response following therapy for PBS/IC-related symptoms also improves
7
Quality of life with painful bladder/interstitial cystitis
Downloaded By: [Consorci de Biblioteques Universitaries de Catalunya] At: 10:07 27 February 2009
QoL aspects. The HRQoL questionnaire used in this
study worked well in PBS/IC, even though it was not
specially designed for this condition. However, the
questions concerning sexuality should be revised.
CyA therapy had more impact on the majority of the
domains of QoL than PPS therapy. Despite DMSO
therapy being more successful than BCG therapy in
the number of treatment responders, DMSO and
BCG therapies had an equal effect on the HRQoL
questionnaire.
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of Arthritis, Diabetes, Digestive and Kidney Diseases Workshop on Interstitial Cystitis, National Institutes of Health,
Bethesda, Maryland, August 2829, 1987. J Urol 1988;140:
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treatment options. Eur Urol 1999;36(Suppl 2):206.
[19] O’Leary MP, Sant GR, Fowler FJ Fr, Whitmore KE,
Spolarich-Kroll J. The interstitial cystitis symptom index
and problem index. Urology 1997;49:5863.
[20] Bogart LM, Berry SH, Clemens JQ. Symptoms of interstitial
cystitis, painful bladder syndrome and similar diseases in
women: a systematic review. J Urol 2007;177:4506.
[21] Nickel JC, Tripp D, Teal V, Propert KJ, Burks D, Foster HE,
et al. Sexual function is a determinant of poor quality of
life for women with treatment refractory interstitial cystitis.
J Urol 2007;177:18326.
[22] Tincello DG, Walker AC. Interstitial cystitis in the UK:
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[23] Peters KM, Killinger KA, Carrico DJ, Ibrahim IA, Diokno
AC, Graziottin A. Sexual function and sexual distress in
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Acknowledgements
The Finnish Urological Association is acknowledged
for funding this work by a grant to the corresponding
author. There is no interest of conflict by any author
named.
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Appendix. Summary of health-related quality
of life questionnaire
1. Your initials
2. In which hospital are you being seen?
3. Today’s date
4. How much pain you have had on average since yesterday?
(110: 1no pain; 10the worst pain you can imagine)
5. Which number best describes your worst pain during the past 7
days? (110: 1no pain; 10the worst pain you can imagine)
6. Which number best describes your least pain during the past 7
days? (110: 1no pain; 10the worst pain you can imagine)
7. How much did your pain interfere with your activities during
the past 7 days? (110: 1not at all; 10extremely)
8. How much of the time, during the past month, has your health
limited your ability to visit with close friends or relatives? (16:
1all of the time; 6none of the time)
9. How much of the time, during the past month, has your health
limited your ability to participate in other social activities?
(16: 1all of the time; 6 none of the time)
10. How much of the time, during the past month, have you been
a very nervous person? (16: 1all of the time; 6none of the
time)
11. During the past month, how much of the time have you felt
calm and peaceful? (16: 1all of the time; 6 none of the time)
12. How much of the time, during the past month, have you felt
downhearted and blue? (16: 1all of the time; 6 none of the
time)
13. During the past month, how much of the time have you been a
happy person? (16: 1all of the time; 6 none of the time)
14. How often, during the past month, have you felt so down in
the dumps that nothing could cheer you up? (16: 1all of the
time; 6 none of the time)
15. How often, during the past month, did you feel dull or
sluggish? (16: 1 all of the time; 6none of the time)
16. During the past month, did you have or feel energy, pep or
vitality? (16: 1 all of the time; 6none of the time)
17. How often, during the past month, have you felt tired, worn
out, used up or exhausted? (16: 1all of the time; 6 none of
the time)
18. For how many days during the past 7 days did you cut down
on the things that you usually do because of your health? (17)
19. For how many days during the past 7 days did you stay in bed
for all or most of the day because of your health? (17)
20. Which number best describes your overall health during the
past month? (110)
21. How much difficulty have you had because of your health
during the past month doing vigorous activities, like lifting heavy
objects, running or participating in sports? (15: 1 no difficulty;
5unable to do)
22. How much difficulty have you had because of your health
during the past month doing moderate activities, like moving a
table, carrying shopping or bowling? (15: 1 no difficulty;
5unable to do)
23. How much difficulty have you had because of your health
during the past month walking uphill or climbing a few flights of
stairs? (15: 1 no difficulty; 5 unable to do)
24. How much difficulty have you had because of your health
during the past month bending, lifting or stooping? (15: 1 no
difficulty; 5 unable to do)
25. How much difficulty have you had because of your health
during the past month going for a short walk outdoors? (15:
1no difficulty; 5unable to do)
26. How much difficulty have you had because of your health
during the past month shaving, dressing, bathing or showering?
(15: 1 no difficulty; 5unable to do)
27. How much did the following statement apply to you during
the past month: ‘‘I was interested in having sex’’? (15: 1 not at
all; 5a great deal)
28. How much did the following statement apply to you during
the past month: ‘‘ I thought others found me sexually attractive’’?
(15: 1 not at all; 5 a great deal)
29. How much did the following statement apply to you during
the past month: ‘‘I felt sexually attractive’’? (15: 1not at all;
5a great deal)
30. Have you tried engage in any type of sexual activity, including
masturbation or intercourse, during the past month? (1 Yes;
2No)
31. How much did the following statement apply to you during
the past month: ‘‘I had difficulty becoming sexually aroused’’?
(15: 1 not at all; 5 a great deal)
33. How much did the following statement apply to you during
the past month: ‘‘I had difficulty reaching orgasm’’? (15: 1not
at all; 5 a great deal)