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Exclusion of Elderly Women From Published Randomized Trials of Stress Incontinence Surgery

Abraham N. Morse, MD^*, Lisa C. Labin, MD, Stephen B. Young, MD, Michael P. Aronson, MD and Jerry H. Gurwitz, MD^*

From the *Meyers Primary Care Institute, University of Massachusetts Medical School and Fallon Foundation; Division of Urogynecology, Department of Obstetrics and Gynecology, University of Massachusetts Medical School; Division of Geriatric Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.

OBJECTIVE: More than 20,000 women, aged 70 years or older, undergo surgery for stress urinary incontinence each year. Our objective was to review the published randomized trials of the surgical treatment of stress urinary incontinence and estimate the proportion of women 70 years or older enrolled in those trials.

DATA SOURCES: MEDLINE and Cochrane Databases of Clinical Trials were searched from January 1966 through December 2003 with the terms "urinary incontinence," "stress incontinence," "urethropexy," "needle suspension," "pubovaginal sling," "tension-free vaginal tape," "urethral injection," "collagen injection," "anterior colporrhaphy," and "clinical trial," "controlled trial," or "randomized trial" as both subject headings and words contained in article titles. We supplemented this search with manual searches of meta-analyses and review articles from 2000 to 2003.

METHODS OF STUDY SELECTION: All studies that included at least one group undergoing an invasive treatment for stress incontinence (including urethral bulking injections) were reviewed. We excluded reports without sufficient data to estimate the number of women aged 70 and older who participated, those published only in abstract form, and those studies in languages other than English, French, German, Italian, or Spanish. Twenty studies met our inclusion criteria.

TABULATION, INTEGRATION, AND RESULTS: The number of women aged 70 or older in each study was estimated using the demographic data provided. The median percentage of subjects aged 70 or older was 3.8% (interquartile range 0.37–15%). There was no significant difference in the proportion of subjects 70 years of age or older based on the year of publication.

CONCLUSION: Our review of the published literature suggests that elderly women are underrepresented in clinical trials of stress incontinence surgery. Efforts should be made to include more elderly women in clinical trials of stress incontinence surgery.