Comprehensive Evaluation of Bladder and Urethral Dysfunction Symptoms: Development and Psychometric Validation of the Urinary Symptom Profile (USP) Questionnaire

doi:10.1016/j.urology.2007.11.100

Urology

Volume 71, Issue 4, April 2008, Pages 646-656

https://doi.org/10.1016/j.urology.2007.11.100 Get rights and content

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 Correlation 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.

Section snippets

Development of the USP

An advisory committee was composed of 4 urologists, 1 specialist in physical medicine and rehabilitation, and specialists in Patient-Reported Outcomes (PROs), who identified and selected an initial list of concepts to be included in the questionnaire, and subsequently drafted the test version of the USP. Qualitative interviews of 7 patients with urinary symptoms and 3 clinicians including 1 urologist, 1 gynecologist, and 1 specialist in physical medicine and rehabilitation, were given to assess

Patients’ Characteristics

A total of 348 patients with either stress UI, urge UI, frequency, low stream, combined symptoms (more of 2 urinary symptoms), or no symptoms were interviewed. Among them, 273 had urinary symptoms and constituted the “symptom group” and 75 had no symptoms and constituted the “control group.” Of the 348 subjects, 328 (94%) satisfied the inclusion criteria and were included in the psychometric validation analysis (253 in the symptom group and 75 in the control group). Their sociodemographic and

Comment

Patient’s outcomes are essential and highly valuable source of information, in that they constitute patients’ subjective assessment in terms of perceptions, beliefs and needs of treatment and/or disease. Thus, the importance of patient perspectives on disease impact and response to therapy is increasingly acknowledged in both medical and pharmaceutical domains, with PROs, including HRQoL, providing relevant information. Applications of PRO instruments are numerous, among which clinical

Conclusions

The USP is the first valid and reliable instrument covering urinary symptoms in both men and women who have stress incontinence, OAB, and obstructive symptoms. It is available in French and in United Kingdom English. This straightforward and brief questionnaire enables the screening and contributes to the differential diagnosis within these urinary disorders, as well as the evaluation of patients’ symptom severity. It would thus be most appropriate for use in everyday practice.

Copyrights

USP is protected by copyright with all rights reserved to the Association Française d’Urologie (AFU). Do not use without permission. However, the AFU kindly encourages the use of the USP by clinicians and researchers. For information on, or permission to use the USP, please contact the Mapi Research Trust, 27 rue de la Villette 69003 Lyon, FRANCE. Tel: +33 (0) 472 13 65 75 - E-mail: [email protected] - website: www.mapi-trust.org.

Acknowledgments

We would like to thank Valérie Bosch (Mapi Values, Lyon) for the statistical analyses, and Christine Le François (Mapi Research Institute) for the linguistic validation. We would like to thank the English native linguist Nicola Barnes (Mapi Values) for reviewing the manuscript. We would also like to thank Dr Berrogain, Dr Boccon-Gibod, Dr Bugel, Dr Ciofu, Dr Conquy, Dr Cortesse, Pr Costa, Pr Coulange, Dr Cour, Pr Delams, Dr Geraud, Dr Grall, Dr Hermieu, Pr Jacquetin, Dr Kouri, Dr Le Normand, Dr

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: Pfizer; Ethicon; and Boston Scientific; Gérard Amarenco is a consultant to pharmacoclinic evaluations to Astratech; Coloplast; Medtronic; Astellas; MSD; Sanofi; Codepharma, Soumitommo; Madaus and Allergan; Benoit Arnould, Khadra Benmedjahed, and Isabelle Guillemin are paid consultants to sponsor (AFU)

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Prostatic Diseases and Male Voiding DysfunctionComprehensive Evaluation of Bladder and Urethral Dysfunction Symptoms: Development and Psychometric Validation of the Urinary Symptom Profile (USP) Questionnaire

Objectives

Methods

Results

Conclusions

Section snippets

Development of the USP

Patients’ Characteristics

Comment

Conclusions

Copyrights

Acknowledgments

Gastroenterology

Eur Urol

Urology

Urology

Urology

J Urol

ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence

Neurourol Urodyn

A health-related quality of life measure for use in patients with urge urinary incontinence: a validation study

Qual Life Res

The impact on health-related quality of life of stress, urge and mixed urinary incontinence

BJU Int

Medical and self-care practices reported by women with urinary incontinence

Am J Manag Care

Help-seeking and associated factors in female urinary incontinenceThe Norwegian EPINCONT Study. Epidemiology of Incontinence in the County of Nord-Trondelag

Scand J Prim Health Care

The ICS-BPH Study: the psychometric validity and reliability of the ICSmale questionnaire

Br J Urol

Validation of the self-administered Danish Prostatic Symptom Score (DAN-PSS-1) system for use in benign prostatic hyperplasia

Br J Urol

Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory: Continence Program in Women (CPW) Research Group

Qual Life Res

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