European

Urology
European Urology 43 (2003) 219225
AReviewof Condition-Specific Instruments to
Assess the Impact of Urinary Incontinence on
Health-Related Quality of Life
Tara Symonds
*
Outcomes Research, Pzer Global Research & Development, Sandwich Laboratories, Sandwich, Kent CT13 9NJ, UK
Accepted 17 January 2003
Abstract
To date, severity of symptoms of urinary tract conditions, such as overactive bladder (OAB) and stress
incontinence, have been the main indicators used to understand the burden on the patient. However, there is also
an impact on patients' health-related quality of life (HRQoL) that should also be assessed. A literature search was
conducted and all HRQoL instruments published in peer-reviewed journals were evaluated. Ten instruments were
identied: general use (ve); urinary urge (OAB) incontinence (four); and stress incontinence (one). Several were
identied as valid instruments for assessing HRQoL in urinary incontinence patients.
# 2003 Elsevier Science B.V. All rights reserved.
Keywords: Health-related quality of life; Incontinence; Assessment method
1. Introduction
Urinary incontinence is the `involuntary loss of
urine, which is objectively demonstrable, and a social
or hygienic problem' [1]. Urinary incontinence can be
dened as follows:
Urinary urge incontinence (UUI): the involuntary
loss of urine associated with a strong desire to void
[1]. More recently, overactive bladder (OAB; urgency
and frequency with or without urge incontinence), a
relatively under-reported condition, has been used to
describe a group of urinary incontinence symptoms
related to UUI [2,3].
Stress incontinence (SI): precipitated when pressure
is exerted on the abdomen, e.g. by coughing.
Mixed incontinence: a mixture of urge and stress
incontinence.
Functional incontinence: physical difcultyin getting
to a toilet, such as mobility problems, sedation, etc.
Assessment of the severity of the symptoms listed
above has been the main indicator used to understand
the burden of the patient's condition. However, there is
also an impact on the person's health-related quality of
life (HRQoL). Loss of urinary control can affect the
social, psychological, domestic, occupational, physical
and sexual aspects of patients' lives [4]. The social and
psychological consequences can be profound, leading
to limitations in social activity, anxiety, embarrassment
and isolation [5]. Incontinent patients are most likely to
restrict their uid intake, restrict physical activity and
avoid places without easy access to toilets [6]. Most
studies carried out in the past decade indicate that urge
symptomatology (including OAB symptoms) impacts
more on HRQoL than stress incontinence [1,7,8].
The prevalence of incontinence depends on the popu-
lation surveyed (type of urinary incontinence, sex and
age). Prevalence in older adults (60 years) in the US
was about 30%, with older women more likely to be
affected [9], particularly by UUI [10]. In a British
survey, incontinence was estimated to be over twice
as prevalent in women (14%) than men (6.6%) [11].
Cost is also an issue. In a survey of incontinent
patients aged 65 years, the cost was estimated to be
$26.3 billion ($3565 per individual) [12]. These costs
are likely to increase with a shift towards a larger
elderly population.
*
Tel. 44-1304-641-553; Fax: 44-1304-658-823.
E-mail address: tara_symonds@sandwich.pzer.com (T. Symonds).
0302-2838/03/$ see front matter # 2003 Elsevier Science B.V. All rights reserved.
doi:10.1016/S0302-2838(03)00045-9
Treatments for incontinence vary from behavioral
therapy to pharmacotherapy. Urge, or OAB sympto-
matology, is probably the most prevalent condition and
pharmacological agents are being developed for these
symptoms. Studies on new and existing treatments
should evaluate HRQoL as well as efcacy. However,
the range of denitions of HRQoL can hinder its
measurement. The general consensus is that physical
health, social health and emotional well-being should
be assessed. Disease-specic instruments are now
more widely used and their suitability for assessing
HRQoL in incontinent patients is presented.
2. Assessment of literature and analytical
methods
Instruments were identied through a systematic
literature search on Medline (19662000) and the
On-Line Guide to Quality of Life Assessment (OLGA)
database [13]. Only instruments that appeared in peer-
reviewed journals were assessed.
Instruments were assessed on rigor of development
and validation. Features assessed were based on the
basic standards for developing and validating a new
HRQoL instrument [14]. The psychometric properties
of each instrument (reliability, validity and sensitivity
to change) were analyzed.
Reliability tests that should ideally be conducted are:
Internal consistency (goodness of t; scale 01
[1 perfect homogeneity of the items in the
domain]. A correlation of >0.95 is excellent internal
consistency.
Reproducibility (testretest reliability): indicates
whether items are stable when no change is
expected. A correlation of scores of >0.9 is excellent
reproducibility.
Basic validity tests that should be conducted are:
Convergent/divergent validity: convergent validity
tests whether the new instrument is actually measur-
ing HRQoL (correlating scores with similar mea-
sures). A correlation of >0.4 would indicate
adequate convergent validity. Divergent validity
tests the new instrument against other instruments.
Known-groups validity: the ability of the instrument
to distinguish between theoretically distinct groups.
Sensitivity to change: this determines whether a
change in HRQoL would be detected if it had
occurred.
3. HRQoL instruments
Tendifferent instruments were identied and split into
three categories: general urinary incontinence (ve),
UUI- or OAB-specic (four) and SI-specic (one).
3.1. General urinary incontinence HRQoL
instruments (Table 1)
3.1.1. King's Health Questionnaire (KHQ)
The KHQ was developed to assess HRQoL in
women with general symptoms of incontinence [15],
but it is also a valid and reliable instrument for use
in both men and women with OAB symptoms [2,16].
It has 21 items representing eight domains: general
Table1
Psychometric properties of HRQoL instruments for general urinary incontinence conditions
a
Instrument Population sample Reliability Validity Sensitivity to
change
Internal
consistency
Testretest Convergent/
divergent
Known-groups
KHQ UIwomen (n 285) @ @ @ @ (10 weeks)
OABmen (n 92) Sensitivity analysis:
OABmen and women (n 338)
ISQ-P UIwomen (n 92)
b
@ @/ @
IIQ UIwomen (n 162) @ @ @ @ (12 weeks)
IIQ-7 UIwomen (n 162)
I-QOL UImen and women (n 62) @ @ @ @ @ (2 weeks)
UIwomen (n 288)
BFLUT
c
UIwomen (n 85)
KHQ, King's Health Questionnaire; ISQ-P, Incontinence Stress Questionnaire for Patients; IIQ, Incontinence Impact Questionnaire; I-QOL, Incontinence
Quality of Life; BFLUT, Bristol Female Lower Urinary Tract symptoms questionnaire.
a
Feature demonstrated (@); feature not demonstrated (); feature not clearly demonstrated (@/).
b
Institutionalized and cognitively impaired.
c
Only reliability and validity scores for the symptom domain were given (not the HRQoL or sexual functioning domain).
220 T. Symonds / European Urology 43 (2003) 219225
health, incontinence impact, role limitations, physical
and social limitations, personal limitations, emotional
problems, sleep/energy disturbance, and severity
measures.
The reliability and validity of the instrument was
assessed in 285 women with various incontinence
symptoms, e.g. stress, detrusor instability, mixed, and
sensory urgency. All domains showed reasonable inter-
nal consistency (alpha scores >0.7) and excellent repro-
ducibility. To test for convergent validity, 193 women
also completed the SF-36 [17] (only the common
domains were correlated). All similar domains were
statistically signicantly correlated with each other
(0.340.64), indicating reasonably good convergence.
The KHQ was sensitive to change in 338 men and
women with OAB receiving either oxybutynin or
tolterodine in a 10-week naturalistic study [2]. Results
from a larger study (n 1284) support this [16,18].
3.1.2. Incontinence Stress Questionnaire for
Patients (ISQ-P)
The ISQ-P was developed to assess the psychologi-
cal distress associated with urinary incontinence in
long-term care [19]. The instrument has 20 items
covering three domains: depression, aesthetic/somatic,
and social functioning. A sample of 96 women (mean
age 85.3 years) was used to assess the psychometrics of
the instrument.
The reliability of the instrument was high (0.90) and
reproducibility (assessed after 11 weeks) showed mod-
erate correlation. Convergent validity was acceptable,
with the relevant domains statistically signicantly
correlating with similar domains on the Center for
Epidemiological Studies-Depression Scale (CES-D)
[20] and the Psychological General Well-Being
(PGWB) instrument [21].
3.1.3. Incontinence Impact Questionnaire (IIQ)
Details of two new instruments for assessing the
impact of urinary incontinence symptoms in women
have been described [22]: the IIQ and Urogenital Dis-
tress Inventory (UDI). The UDI is not reviewed because
it is more a measure of `bothersomeness' of symptoms
than an assessment of HRQoL. The IIQ questionnaire
has 30 items comprising four domains: physical activity,
travel, social relationships and emotional health.
Internal consistency was high for each domain (all
>0.86) and convergent validity of IIQ was demon-
strated. Testretest reliability was not assessed. Sen-
sitivity was shown with a signicant change in
all domains seen over a 3-month treatment period
(behavioral intervention, estrogen replacement therapy
or surgical treatment).
Since the initial development of IIQ, a short-form
version has been produced which uses seven items
from each domain of the original version [23]. Validity
and reliability analyses of the IIQ-7 were not given and
no additional papers documenting its psychometric
properties were identied in the literature.
3.1.4. Incontinence Quality of Life Instrument
(I-QOL)
The 22 items of the I-QOL were produced by inter-
viewing patients with urge, stress and mixed incon-
tinence [24]. Psychometric testing of the instrument
was carried out using 62 urinary incontinent patients.
Reliability of the instrument was excellent. Correla-
tions with both the PGWBand the functioning items on
the SF-36 indicated satisfactory convergent validity.
Known-groups validity was also shown, the I-QOL
scores being signicantly (p < 0:0001) worse as sever-
ity, self-perceived severity, and number of medical
appointments to treat incontinence in the past year
increased.
Further developments to the I-QOL instrument have
been described in a study involving 141 stress and 147
mixedincontinent women[25]. The internal consistency
(0.95), reproducibility (0.91), convergent validity, and
sensitivity to change of the instrument were conrmed.
3.1.5. Bristol Female Lower Urinary Tract symptoms
questionnaire (BFLUT)
The BFLUT assesses symptom bothersomeness (20
items), HRQoL (nine items), and sexual function (four
items) [26]. Only validation details of the 20-symptom/
bother items were presented. To date, no information
on the validation of the HRQoL/sexual function items
is available.
3.1.6. Evaluation
Four of ve instruments developed to assess impact of
general incontinence symptoms on HRQoL have good
reliability and validity data. The KHQ has reliable and
valid properties for use in incontinent women, with
further testing of the instrument demonstrating its use
in both men and women with OAB. The eight domains
of the KHQensure that HRQoL issues are covered. The
I-QOL is a well-validated instrument, particularly in
women who have stress incontinence or mixed incon-
tinence. Total score may not be relevant if specic
aspects of HRQoL are targeted for assessment, for
example, if a particular therapy is more likely to impact
positively on some aspects of HRQoL than others.
The IIQ also appears to be a reliable and valid
instrument for assessing the impact of general incon-
tinence symptoms in women. The short-form version,
T. Symonds / European Urology 43 (2003) 219225 221
IIQ-7, will need complete validation and reliability
testing before recommendations can be made. Further-
more, although the ISQ-P showed some acceptable
psychometric results it is, perhaps, the most restricted
instrument in terms of use, i.e. cognitively impaired,
institutionalized women.
The BFLUT requires appropriate testing of the
whole instrument, including the HRQoL and sexual
functioning items, before further recommendations are
made. Arguably, instruments specically designed to
assess HRQoL issues will be able to cover more than
the nine items of the BFLUT.
Urinary incontinence may not be as prevalent in men
as in women but the impact of symptoms on HRQoL is
the same [27]. Therefore, instruments should also be
developed and validated for use in men. The I-QOL,
IIQ and ISQ-P need further testing before use in
incontinent men, while the KHQ requires further test-
ing in men with incontinence symptoms other than
OAB.
I-QOL, IIQ and KHQ have demonstrated sensitivity
to change, but only the KHQ has shown this in men.
The I-QOL needs to be tested over a treatment period
>2 weeks. No data are available about changes related
to placebo-like effects and, thus, the clinical mean-
ingfulness of the changes in HRQoL is difcult to
ascertain.
3.2. Urge incontinent-specic (or OAB) HRQoL
(Table 2)
3.2.1. King's Health Questionnaire (KHQ)
Refer to general incontinence section.
3.2.2. Incontinence Quality of Life Index (IQoLI)
The IQoLI instrument addresses the social, emo-
tional and physical impact of UUI symptoms using 29
questions [28]. Reliability and validity were tested in a
double-blind, randomized clinical trial involving 79
women. Four items were insensitive to change and
were dropped from further analyses.
The remaining 25-item instrument showed good
reliability (reproducibility 0.92, internal consistency
0.9). Convergent validity with the PGWB [21] instru-
ment was adequate (0.4). The sensitivity of the instru-
ment to change was demonstrated over 3 months of
treatment with emepronium carrageenate or placebo.
Additional evidence of sensitivity to change was
demonstrated in a 12-week trial in 214 OAB patients
receiving oxybutynin, tolterodine or placebo [2].
3.2.3. Quality of Life Questionnaire for Urgent
Micturition
The Urgent Micturition instrument has 24 items
grouped into ve dimensions: activities (eight items),
emotional repercussions (ve), self-image (ve), sleep
(three), and well-being (three) [29].
The internal reliability and reproducibility of the
dimensions were sufcient with scores of >0.70 and
>0.80, respectively. The known-groups validity was
also goodscores were signicantly lower as symp-
toms increased in severity. Convergent validity and
sensitivity to change were not reported.
3.2.4. Urge Impact Scale
The Urge Impact Scale (URIS-24) measures three
areas of HRQoL: psychological burden, personal con-
trol, and self-concept [30]. To assess its psychometric
properties the URIS-24 was administered to 48 urge
incontinent patients aged 5789 years.
The internal consistency of the whole instrument was
excellent (0.94), as was testretest reliability (0.88). The
validity of the instrument was determined by correlating
Table 2
Psychometric properties of HRQoL instruments for use in urinary urge specic conditions
a
Instrument Population sample Reliability Validity Sensitivity to
change
Internal
consistency
Testretest Convergent/
divergent
Known-groups
IQoLI UUIwomen (n 79) @ @ @ @ @ (12 weeks)
Sensitivity to changeOAB men
and women (n 214)
QoL Questionnaire for
Urgent Micturitions
Urgent micturitionswomen (n 98) @ @ @
URIS-24 UUImen and women (n 48) @ @
Urge Incontinence
Impact Questionnaire
UUIwomen (n 83) @ @ @/ @ @ (12 weeks)
UUImen and women (n 257)
IQoLI, Incontinence Quality of Life Index; QoL, Quality of Life; URIS-24, Urge Impact Scale.
a
Feature demonstrated (@); feature not demonstrated (); feature not clearly demonstrated (@/).
222 T. Symonds / European Urology 43 (2003) 219225
incontinence frequency with URIS-24 scores; the result
was ambiguous. Known-groups validity and sensitivity
to change were not analyzed.
3.2.5. Urge Incontinence Impact Questionnaire
(U-IIQ)
Urge-specic items have been added to the domains
of the IIQ[31]. The additional items were developed by
focus group interviews, clinical opinion and literature
review, and the new instrument tested on women with
urge or mixed incontinence (n 83). Forty women
completed the instrument twice over a 2-week period.
The U-IIQ has six domains: travel, activities, feelings,
physical activities, relationships, and sexual function.
Internal consistency for all domains was high (>0.90),
except the physical activities domain (0.74). Testretest
reliability was good for activities, feelings and relation-
ships (>0.85), while physical activities, travel and sex-
ual function had acceptable values (>0.70). Convergent
and divergent validity were addressed by correlating U-
IIQ domains with the respective domains of the SF-36.
However, the resulting correlation coefcients did not
clearly conrm convergent validity. The known-groups
validity and sensitivity to change of the instrument has
also since been reported [32].
3.2.6. Evaluation
The most promising of the three urge incontinent
specic instruments is the U-IIQ. Two studies have
provided psychometric evidence for its reliability,
validity and sensitivity to change [31,32]; however,
specic validation in men is needed. The sexual func-
tion domain is the weakest domain, possibly because of
the lownumber of sexually active participants (n 23)
[31]. For wider use in evaluating new treatments in
incontinence more evidence should be provided on the
instrument's ability to detect a clinically meaningful
changethe changes documented for the U-IIQ were
not large. Its sensitivity also needs to be determined
versus placebo.
The KHQ has been specically tested in OAB
patients and its consideration for use is warranted,
not only because it has been validated in both men
and women, but also because of its sensitivity to change
in this group.
The IQoLI has acceptable reliability and validity, but
discrepancies in its sensitivity to change means that its
clinical meaningfulness is difcult to determine.
Further work is needed to clarify this.
The URIS-24 is a promising instrument for use in
UUI patients regardless of sex, despite that fact that
psychometric analyses have been limited to 48-year-
old UUI patients to date. Additional testing is neces-
sary before recommendations can be made. Further-
more, a greater understanding is required of the
divergent, convergent and known-groups validity of
the instrument and, if the instrument is considered for
use in clinical trials, its sensitivity to change.
The Quality of Life Questionnaire for Urgent Mic-
turition showed good general psychometric properties
but its applicability is limited because of the selection of
female patients with symptoms of urgent micturition.
3.3. Stress incontinence specic HRQoL instrument
(Table 3)
3.3.1. Symptom Impact Index for Stress Incontinence
Two instruments were developed: one to assess
symptom severity and the other to assess symptom
impact. The symptom impact instrument measures the
effect on HRQoL (11 items) and is reviewed here.
Using a sample of 442 women, various psychometric
analyses were conducted. Internal consistency of the
SII-SI was reasonable at 0.77, and testretest reliability
was satisfactory [33]. Prior surgery and body mass
index (BMI) were used to assess convergent validity.
There was poor correlation with prior surgery but
signicant correlation with BMI. Known-groups valid-
ity was poor, with no discrimination between groups
with different lengths of history with SI.
3.3.2. Evaluation
Althoughthe SII-SI items were thoroughlyresearched
for comprehensibility and relevance some of the psy-
chometric properties were questionable. For example,
correlating scores with BMI determined the convergent
validity of the instrument, but why this was chosen over
Table 3
Psychometric properties of HRQoL instruments for stress incontinence conditions
a
Instrument Population sample Reliability Validity Sensitivity to change
Internal consistency Testretest Convergent/divergent Known-groups
SII-SI SIwomen (n 442) @ @ @
SII-SI, Symptom Impact Index for Stress Incontinence.
a
Feature demonstrated (@); feature not demonstrated ().
T. Symonds / European Urology 43 (2003) 219225 223
more suitable assessments of convergent validity, such
as similar constructs on other HRQoL instruments, is
unknown. Known-groups validity was not shown which
suggests poor sensitivity to change. Currently, one of the
general incontinence instruments may be a better start-
ing point to determine HRQoL in SI women.
4. Conclusions
There are a number of reliable and valid instruments
for assessing the impact of incontinence symptomatol-
ogy on HRQoL. Currently, the general instruments are
the more psychometrically robust, particularly the KHQ
[15] and I-QoL[24]. Of the specic UUI instruments, U-
UIIQ [31] is a promising instrument for assessing
HRQoL in OAB (or UUI) patients. The KHQ, a general
incontinence questionnaire, is alsoanappropriate instru-
ment for use in OABpatients. SII-SI, specically devel-
opedfor use inSI patients, requires further psychometric
assessment before recommendations can be made.
Choice of instrument will invariably be decided by
the population under consideration. If an instrument is
chosen that has not been validated for that group, then
validity testing should be a primary objective. Patrick
et al. [25] highlighted this issue when they obtained
lower convergent validity correlations between the I-
QOL and other instruments than previously obtained
by others [24], noting it was ``possibly due to differ-
ences in study populations that included men''. Instru-
ments showing strong psychometric properties in one
group may not display this property in another group.
Before deciding on an instrument, the content of the
instrument's items should be thoroughly reviewed to
ensure that a particular aspect of HRQoL does not need
additional assessment. For example, if the aim is to
ascertain the impact of incontinence on sleep and
energy issues then the KHQ might be a more useful
tool to use over, say, the I-QOL, in which a total score is
calculated.
Overall, most instruments were tested for the appro-
priate features of reliability, validity and sensitivity to
change, with many showing sufcient properties. The
number of instruments with data on sensitivity to
change was encouraging but the clinical meaningful-
ness of these changes needs more exploration.
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