Prostatic Diseases and Male Voiding Dysfunction
Comprehensive Evaluation of Bladder
and Urethral Dysfunction Symptoms:
Development and Psychometric Validation
of the Urinary Symptom Profile (USP)
Questionnaire
François Haab, François Richard, Gérard Amarenco, Patrick Coloby, Benoit Arnould,
Khadra Benmedjahed, Isabelle Guillemin, and Philippe Grise
OBJECTIVES To develop and validate a standardized tool assessing urinary symptoms among men and women
with stress, urge, frequency, or urinary obstructive symptoms for use in clinical practice to
complement clinical measures and diagnosis.
METHODS After development by an advisory committee and comprehension testing with patients, the Urinary
Symptoms Profile (USP) item content and validity were evaluated by clinicians. Patients with urinary
symptoms (n ⫽ 253) and without symptoms (n ⫽ 75) completed the final questionnaire at day 0 and
day 7. Psychometric properties were assessed, including construct and clinical validity, reliability, and
predictive ability for detection of and differentiation between urinary disorders.
RESULTS Principal Component Analysis with Varimax Rotation confirmed the final USP structure of 13
items in 3 dimensions: stress urinary incontinence (SUI), overactive bladder (OAB), and low
stream (LS). Internal consistency reliability (Cronbach’s alpha ranging from 0.69 to 0.94) and
concurrent validity (Spearman correlation coefficients between International Consultation on
Incontinence Questionnaire and SUI and OAB dimensions of 0.73 and 0.62, respectively) were
good. Test-retest reproducibility over 7 days was excellent in stable patients (Intraclass Corre-
lation Coefficients from 0.84 to 0.91). USP clinical validity was demonstrated by comparing
micturition diary with USP scores. USP dimension scores were excellent predictors of urinary
disorder presence and identification.
CONCLUSIONS USP is the first valid and reliable questionnaire providing comprehensive evaluation of all
urinary disorders and their severity in both men and women with SUI, OAB, and LS. It allows
the screening and contributes to the differential diagnosis of these symptoms. The USP is a
valuable tool for use in clinical practice. UROLOGY 71: 646 – 656, 2008. © 2008 Elsevier Inc.
U
rinary disorders are common health problems diagnosed: stress UI, urge UI, and mixed UI. Stress UI is
that negatively affect patient Health-Related the most common type of UI in younger women, whereas
Quality of Life (HRQoL).1–7Among these, uri- urge UI and mixed incontinence (combination of stress
nary incontinence (UI) is encountered in both genders, and urge UI symptoms), are commonly diagnosed in
and can be classified into 3 major groups most frequently elderly women. Low urinary stream that may result from
benign prostatic hyperplasia (BPH) in men, constitutes
Pfizer; Ethicon; and Boston Scientific; Gérard Amarenco is a consultant to pharmaco-
another frequent type of urinary disorder.
clinic evaluations to Astratech; Coloplast; Medtronic; Astellas; MSD; Sanofi; Codep- Although efficient treatments are available only few
harma, Soumitommo; Madaus and Allergan; Benoit Arnould, Khadra Benmedjahed, patients are under medical care,8,9 likely to be related to
and Isabelle Guillemin are paid consultants to sponsor (AFU)
B. Arnould, K Benmedjahed, and I. Guillemin are paid consultants to Association an underreporting of symptoms, which may be explained
Française d’Urologie by the lack of information about treatments, patients’
The study was funded by the “Association Française d’Urologie” (AFU) embarrassment in discussing their condition, and/or the
From the Hôpital Ténon, Paris, France; Hôpital de La Pitié-Salpêtrière, Paris,
France; Department of Neurologic Rehabilitation, Urodynamic and Neurophysiology misconception that urinary disorders, especially UI, are a
Laboratory, Rothschild Hospital, Paris,France; Centre Hospitalier René Dubos, Pon- natural consequence of aging.
toise, France; Mapi Values, Lyon, France; and Hôpital Charles Nicolle, Rouen, France Diagnosis mainly relies on patients’ own clinical his-
Reprint requests: Isabelle Guillemin, Ph.D., 27, Rue de la Villette, 69003 Lyon,
France. E-mail: tory and symptom description to clinicians, combined
Submitted: July 30, 2007, accepted (with revisions): November 20, 2007 with a physical examination and urinalysis. Micturition
646 © 2008 Elsevier Inc. 0090-4295/08/$34.00
All Rights Reserved doi:10.1016/j.urology.2007.11.100
, diaries and urinary questionnaires allow a comprehensive 0 to day 7 reporting urgency, number of incontinence epi-
evaluation of symptoms, among which some specifically sode(s), number of micturition episode(s), and voided volume
assess symptoms of urinary disorders.1 However, to our per micturition. The urologist completed a medical form for
knowledge, these instruments often either; concern each patient at baseline.
women or men, and/or a specific urinary disorder, thus
leading to multiple scores that are difficult to compare Statistical Analysis
from 1 study to another; or assess urinary symptoms and The questionnaire structure was assessed using Principal Com-
severity before diagnosis.1,3,5,10 –13 None combine symp- ponent Analysis (PCA) with Varimax Rotation.16 Item con-
vergent validity was measured by using multitrait analysis.17
toms of urinary incontinence together with low stream
Cronbach’s alpha was calculated to assess the internal consis-
symptoms frequently associated with BPH. Furthermore, tency reliability.18 Floor and ceiling effects were determined as
they do not assess side effects like those induced by the percentage of patients with the lowest and the highest
therapeutics or medical intervention (such as voiding scores. Questionnaire reproducibility was evaluated in stable
difficulties when evaluating the impact of stress inconti- patients from day 0 to day 7 by using a Wilcoxon signed rank
nence surgery). test, Intraclass Correlation Coefficient (ICC), and Concor-
A new specific questionnaire, the Urinary Symptom dance Correlation Coefficient (CCC) determination.19,20 Sub-
Profile (USP), assessing stress incontinence, overactive jects were considered clinically stable when he/she answered
bladder, and urinary obstruction symptoms in both men “No” to the 4 items added to USP to assess patient stability at
and women was designed. The main purpose of the day 7. The predictive power of the scores was assessed by using
instrument is to complement the clinician’s diagnosis the area under receiving operating characteristic (ROC) curve,
which was estimated with the use of the concordance index.21
with the patient’s subjective outcomes regarding their
Spearman correlation coefficients were determined to analyze
medical status. This article describes the development the correlation between quantitative and/or ordinal data. A
and psychometric validation of the instrument. Its ability Mann-Whitney Wilcoxon test (2 groups of patients) or a
to differentiate the type of urinary disorder according to Kruskal-Wallis test (3 groups or more) was performed to com-
patients’ symptoms is discussed. pare groups of subjects with quantitative or ordinal data. The
This work was presented at the ISOQOL Conference threshold for statistical significance was set at 5%.
on Patient-Reported Outcomes in Clinical Practice.14 Multitrait analysis was performed by using MAP-R (Multi-
trait Analysis program) for Windows, Version 1. Other analyses
were carried out with SAS software (Statistical Analysis Sys-
MATERIAL AND METHODS tem, Version 9.1.3, SAS Institute Inc, Cary, NC).
Development of the USP
An advisory committee was composed of 4 urologists, 1 special- RESULTS
ist in physical medicine and rehabilitation, and specialists in
Patient-Reported Outcomes (PROs), who identified and se- Patients’ Characteristics
lected an initial list of concepts to be included in the question- A total of 348 patients with either stress UI, urge UI,
naire, and subsequently drafted the test version of the USP. frequency, low stream, combined symptoms (more of 2
Qualitative interviews of 7 patients with urinary symptoms and urinary symptoms), or no symptoms were interviewed.
3 clinicians including 1 urologist, 1 gynecologist, and 1 special- Among them, 273 had urinary symptoms and constituted
ist in physical medicine and rehabilitation, were given to assess the “symptom group” and 75 had no symptoms and
comprehension of the test questionnaire, its structure, and
constituted the “control group.” Of the 348 subjects, 328
validity. Patients were asked to provide detailed comments
regarding each item, while clinicians were asked to comment on
(94%) satisfied the inclusion criteria and were included
the items’ relevance. The questionnaire was then reorganized in the psychometric validation analysis (253 in the symp-
and retested on 25 other subjects (21 with urinary symptoms tom group and 75 in the control group). Their sociode-
and 4 healthy). mographic and clinical characteristics were gathered
The final questionnaire was adapted into United Kingdom from the completed medical form (Table 1).
English by using standard linguistic translation methodology.15
Psychometric Properties
Study Design The developed pilot questionnaire contained 16 items.
A cross-sectional, multicenter, observational and anonymous To analyze its structure, a PCA with Varimax Rotation
study was conducted by 22 urologists. Two hundred seventy- was performed at baseline with UI subjects with no
three subjects with urinary symptoms, including urge UI, stress missing data (n ⫽ 183). Factor analysis resulted in 3
UI, low stream (LS), frequency, and combination were re- factors with eigenvalues greater than 1, accounting for
cruited. A control group of 75 subjects with no urinary symp-
63% of the total variance, allowing the definition of 3
toms was also included in the study. All patients completed the
USP on the day of their inclusion (day 0), and 7 days thereafter
dimensions referred to as “Stress UI” (SUI) dimension,
(day 7), together with the International Consultation on In- “overactive bladder” (OAB) dimension, and “low
continence Questionnaire-Urinary Incontinence short form stream” (LS) dimension. Because of high redundancy
(ICIQ-UI SF) that evaluates frequency, prevalence, and per- across the 6 items covering stress UI, 3 of them were
ceived cause of urinary incontinence, and its impact on every- excluded from further analyses.
day life.3 Patients also completed a micturition diary from day The final USP questionnaire consisted of 13 items
UROLOGY 71 (4), 2008 647
Comprehensive Evaluation of Bladder
and Urethral Dysfunction Symptoms:
Development and Psychometric Validation
of the Urinary Symptom Profile (USP)
Questionnaire
François Haab, François Richard, Gérard Amarenco, Patrick Coloby, Benoit Arnould,
Khadra Benmedjahed, Isabelle Guillemin, and Philippe Grise
OBJECTIVES To develop and validate a standardized tool assessing urinary symptoms among men and women
with stress, urge, frequency, or urinary obstructive symptoms for use in clinical practice to
complement clinical measures and diagnosis.
METHODS After development by an advisory committee and comprehension testing with patients, the Urinary
Symptoms Profile (USP) item content and validity were evaluated by clinicians. Patients with urinary
symptoms (n ⫽ 253) and without symptoms (n ⫽ 75) completed the final questionnaire at day 0 and
day 7. Psychometric properties were assessed, including construct and clinical validity, reliability, and
predictive ability for detection of and differentiation between urinary disorders.
RESULTS Principal Component Analysis with Varimax Rotation confirmed the final USP structure of 13
items in 3 dimensions: stress urinary incontinence (SUI), overactive bladder (OAB), and low
stream (LS). Internal consistency reliability (Cronbach’s alpha ranging from 0.69 to 0.94) and
concurrent validity (Spearman correlation coefficients between International Consultation on
Incontinence Questionnaire and SUI and OAB dimensions of 0.73 and 0.62, respectively) were
good. Test-retest reproducibility over 7 days was excellent in stable patients (Intraclass Corre-
lation Coefficients from 0.84 to 0.91). USP clinical validity was demonstrated by comparing
micturition diary with USP scores. USP dimension scores were excellent predictors of urinary
disorder presence and identification.
CONCLUSIONS USP is the first valid and reliable questionnaire providing comprehensive evaluation of all
urinary disorders and their severity in both men and women with SUI, OAB, and LS. It allows
the screening and contributes to the differential diagnosis of these symptoms. The USP is a
valuable tool for use in clinical practice. UROLOGY 71: 646 – 656, 2008. © 2008 Elsevier Inc.
U
rinary disorders are common health problems diagnosed: stress UI, urge UI, and mixed UI. Stress UI is
that negatively affect patient Health-Related the most common type of UI in younger women, whereas
Quality of Life (HRQoL).1–7Among these, uri- urge UI and mixed incontinence (combination of stress
nary incontinence (UI) is encountered in both genders, and urge UI symptoms), are commonly diagnosed in
and can be classified into 3 major groups most frequently elderly women. Low urinary stream that may result from
benign prostatic hyperplasia (BPH) in men, constitutes
Pfizer; Ethicon; and Boston Scientific; Gérard Amarenco is a consultant to pharmaco-
another frequent type of urinary disorder.
clinic evaluations to Astratech; Coloplast; Medtronic; Astellas; MSD; Sanofi; Codep- Although efficient treatments are available only few
harma, Soumitommo; Madaus and Allergan; Benoit Arnould, Khadra Benmedjahed, patients are under medical care,8,9 likely to be related to
and Isabelle Guillemin are paid consultants to sponsor (AFU)
B. Arnould, K Benmedjahed, and I. Guillemin are paid consultants to Association an underreporting of symptoms, which may be explained
Française d’Urologie by the lack of information about treatments, patients’
The study was funded by the “Association Française d’Urologie” (AFU) embarrassment in discussing their condition, and/or the
From the Hôpital Ténon, Paris, France; Hôpital de La Pitié-Salpêtrière, Paris,
France; Department of Neurologic Rehabilitation, Urodynamic and Neurophysiology misconception that urinary disorders, especially UI, are a
Laboratory, Rothschild Hospital, Paris,France; Centre Hospitalier René Dubos, Pon- natural consequence of aging.
toise, France; Mapi Values, Lyon, France; and Hôpital Charles Nicolle, Rouen, France Diagnosis mainly relies on patients’ own clinical his-
Reprint requests: Isabelle Guillemin, Ph.D., 27, Rue de la Villette, 69003 Lyon,
France. E-mail: tory and symptom description to clinicians, combined
Submitted: July 30, 2007, accepted (with revisions): November 20, 2007 with a physical examination and urinalysis. Micturition
646 © 2008 Elsevier Inc. 0090-4295/08/$34.00
All Rights Reserved doi:10.1016/j.urology.2007.11.100
, diaries and urinary questionnaires allow a comprehensive 0 to day 7 reporting urgency, number of incontinence epi-
evaluation of symptoms, among which some specifically sode(s), number of micturition episode(s), and voided volume
assess symptoms of urinary disorders.1 However, to our per micturition. The urologist completed a medical form for
knowledge, these instruments often either; concern each patient at baseline.
women or men, and/or a specific urinary disorder, thus
leading to multiple scores that are difficult to compare Statistical Analysis
from 1 study to another; or assess urinary symptoms and The questionnaire structure was assessed using Principal Com-
severity before diagnosis.1,3,5,10 –13 None combine symp- ponent Analysis (PCA) with Varimax Rotation.16 Item con-
vergent validity was measured by using multitrait analysis.17
toms of urinary incontinence together with low stream
Cronbach’s alpha was calculated to assess the internal consis-
symptoms frequently associated with BPH. Furthermore, tency reliability.18 Floor and ceiling effects were determined as
they do not assess side effects like those induced by the percentage of patients with the lowest and the highest
therapeutics or medical intervention (such as voiding scores. Questionnaire reproducibility was evaluated in stable
difficulties when evaluating the impact of stress inconti- patients from day 0 to day 7 by using a Wilcoxon signed rank
nence surgery). test, Intraclass Correlation Coefficient (ICC), and Concor-
A new specific questionnaire, the Urinary Symptom dance Correlation Coefficient (CCC) determination.19,20 Sub-
Profile (USP), assessing stress incontinence, overactive jects were considered clinically stable when he/she answered
bladder, and urinary obstruction symptoms in both men “No” to the 4 items added to USP to assess patient stability at
and women was designed. The main purpose of the day 7. The predictive power of the scores was assessed by using
instrument is to complement the clinician’s diagnosis the area under receiving operating characteristic (ROC) curve,
which was estimated with the use of the concordance index.21
with the patient’s subjective outcomes regarding their
Spearman correlation coefficients were determined to analyze
medical status. This article describes the development the correlation between quantitative and/or ordinal data. A
and psychometric validation of the instrument. Its ability Mann-Whitney Wilcoxon test (2 groups of patients) or a
to differentiate the type of urinary disorder according to Kruskal-Wallis test (3 groups or more) was performed to com-
patients’ symptoms is discussed. pare groups of subjects with quantitative or ordinal data. The
This work was presented at the ISOQOL Conference threshold for statistical significance was set at 5%.
on Patient-Reported Outcomes in Clinical Practice.14 Multitrait analysis was performed by using MAP-R (Multi-
trait Analysis program) for Windows, Version 1. Other analyses
were carried out with SAS software (Statistical Analysis Sys-
MATERIAL AND METHODS tem, Version 9.1.3, SAS Institute Inc, Cary, NC).
Development of the USP
An advisory committee was composed of 4 urologists, 1 special- RESULTS
ist in physical medicine and rehabilitation, and specialists in
Patient-Reported Outcomes (PROs), who identified and se- Patients’ Characteristics
lected an initial list of concepts to be included in the question- A total of 348 patients with either stress UI, urge UI,
naire, and subsequently drafted the test version of the USP. frequency, low stream, combined symptoms (more of 2
Qualitative interviews of 7 patients with urinary symptoms and urinary symptoms), or no symptoms were interviewed.
3 clinicians including 1 urologist, 1 gynecologist, and 1 special- Among them, 273 had urinary symptoms and constituted
ist in physical medicine and rehabilitation, were given to assess the “symptom group” and 75 had no symptoms and
comprehension of the test questionnaire, its structure, and
constituted the “control group.” Of the 348 subjects, 328
validity. Patients were asked to provide detailed comments
regarding each item, while clinicians were asked to comment on
(94%) satisfied the inclusion criteria and were included
the items’ relevance. The questionnaire was then reorganized in the psychometric validation analysis (253 in the symp-
and retested on 25 other subjects (21 with urinary symptoms tom group and 75 in the control group). Their sociode-
and 4 healthy). mographic and clinical characteristics were gathered
The final questionnaire was adapted into United Kingdom from the completed medical form (Table 1).
English by using standard linguistic translation methodology.15
Psychometric Properties
Study Design The developed pilot questionnaire contained 16 items.
A cross-sectional, multicenter, observational and anonymous To analyze its structure, a PCA with Varimax Rotation
study was conducted by 22 urologists. Two hundred seventy- was performed at baseline with UI subjects with no
three subjects with urinary symptoms, including urge UI, stress missing data (n ⫽ 183). Factor analysis resulted in 3
UI, low stream (LS), frequency, and combination were re- factors with eigenvalues greater than 1, accounting for
cruited. A control group of 75 subjects with no urinary symp-
63% of the total variance, allowing the definition of 3
toms was also included in the study. All patients completed the
USP on the day of their inclusion (day 0), and 7 days thereafter
dimensions referred to as “Stress UI” (SUI) dimension,
(day 7), together with the International Consultation on In- “overactive bladder” (OAB) dimension, and “low
continence Questionnaire-Urinary Incontinence short form stream” (LS) dimension. Because of high redundancy
(ICIQ-UI SF) that evaluates frequency, prevalence, and per- across the 6 items covering stress UI, 3 of them were
ceived cause of urinary incontinence, and its impact on every- excluded from further analyses.
day life.3 Patients also completed a micturition diary from day The final USP questionnaire consisted of 13 items
UROLOGY 71 (4), 2008 647
