OBJECTIVE: To estimate whether prolapse severity is a major contributor to urinary incontinence severity, as measured by validated incontinence questionnaires.
METHODS: We analyzed data from two large female stress urinary incontinence (SUI) surgical cohorts: the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) study (N=655) and the subsequent Trial of Mid-Urethral Slings (TOMUS) study (N=597). All participants completed a standardized baseline assessment including validated measures of symptom severity, quality of life, objective measures of urine loss (Urogenital Distress Inventory [UDI], Medical, Epidemiologic, and Social Aspects of Aging questionnaire, Incontinence Impact Questionnaire, and pad test), as well as the Pelvic Organ Prolapse Quantification assessment. Groups were compared using the χ2; test (categorical measures) or the one-way analysis of variance (continuous measures). Statistical significance was defined as P<.05.
RESULTS: The SISTEr and TOMUS samples were similar for many variables including age (52 and 53 years, respectively), nulliparity (9% and 12%), prior urinary incontinence (UI) surgery (14% and 13%), and prior hysterectomy (31% and 28%), but other differences necessitated separate analysis of the two cohorts. There was not a statistically significant difference in UDI scores according to prolapse stage in either study population. Patients with prior surgery for pelvic organ prolapse and SUI had more incontinence symptoms and were more bothered by their UI regardless of prolapse stage.
CONCLUSION: Prolapse stage is not strongly or consistently associated with incontinence severity in women who select surgical treatment of SUI. Prior pelvic organ prolapse and UI surgery is associated with worse UI severity and bother.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00064662 and NCT00325039.
LEVEL OF EVIDENCE: II
In women with stress urinary incontinence symptoms sufficient to undergo surgery, the pelvic organ prolapse quantification prolapse stage is not a major factor in urinary incontinence symptom severity.
From the Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago, Stritch School of Medicine, Chicago, Illinois; the Department of Urology, University of Maryland, Baltimore, Maryland; the New England Research Institutes, Watertown, Massachusetts; the Birmingham VA Medical Center and the Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas; the Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania; Kaiser Permanente, San Diego, California; the Department of Urology, William Beaumont Hospital, Royal Oak, Michigan; the Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.
Supported by cooperative agreements from the National Institute of Diabetes and Digestive and Kidney Diseases, U01 DK58225, U01 DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01 DK60380, U01 DK60393, U01 DK60395, U01 DK60397, and 60401. Support also was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Office of Research in Women’s Health, National Institutes of Health.
The authors thank the other investigators of the Urinary Incontinence Treatment Network, listed at uitn.org, who participated in the design, conduct, and analysis of these studies.
Corresponding author: Linda Brubaker, MD, MS, Loyola University Chicago, Stritch School of Medicine, 2160 South First Avenue, Building 103, Room 1004, Maywood, IL 60153; e-mail: LBrubaker@lumc.edu.
Financial Disclosure: Dr. Brubaker has received research funding from Pfizer (New York, NY) and Allergan (Irvine, CA) and has been a research consultant for Pfizer. Dr. Lemak has been a clinical trial participant for Allergan, a consultant and lecturer for Astellas (Deerfield, IL) and Pfizer, and a lecturer for Novartis (Basel, Switzerland). Dr. Ghetti served as a co-investigator for the Bridges study with the University of California, San Francisco, which was partially funded by Pfizer. The other authors did not report any potential conflicts of interest.