Background Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. Methods We performed a multicenter, randomized clinical trial comparing two procedures — the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension — among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events. Results A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P = 0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence. Conclusions The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension.
Bibliographical noteFunding Information:
Supported by cooperative agreements (U01 DK58225, U01DK58229, U01 DK58234, U01 DK58231, U01 DK60379, U01DK60380, U01 DK60393, U01 DK60395, U01 DK60397, and U01 DK60401) with the National Institute of Diabetes and Digestive and Kidney Diseases and by the National Institute of Child Health and Human Development and Office of Research in Women?s Health of the National Institutes of Health. Dr. Albo reports receiving consulting fees from Pfizer and Astellas and grant support from Pfizer; Dr. Richter, receiving lecture fees from Pfizer, Esprit Pharmaceutical, and Indevus Pharmaceuticals and grant support from Pfizer; Dr. Brubaker, receiving consulting fees from Pfizer and Q-Med and grant support from Q-Med, Allergan, and Pfizer; Dr. Norton, receiving consulting fees from Eli Lilly; Dr. Kraus, receiving consulting fees from Lilly ICOS and Pfizer, lecture fees from Novartis, Astellas, Pfizer, and Ortho-McNeil, and grant support from Pfizer and GlaxoSmithKline; Dr. Chai, receiving consulting fees from Astellas and Pfizer and grant support from Pfizer; Dr. Zyczynski, receiving consulting fees from Ethicon and grant support from Novartis and Johnson & Johnson; Dr. Diokno, receiving lecture fees from Astellas, Medtronic, Janssen-Cilag, and Ortho-McNeil, and grant support from GlaxoSmithKline, Allergon, and Allergan, and holding a patent on a modified vaginal speculum marketed by Mentor; Dr. Tennstedt, receiving grant support from Lilly ICOS; Dr. Lloyd, receiving consulting fees from Novartis, GlaxoSmithKline, Pfizer, and AMS, lecture fees from Lilly ICOS, Ortho-McNeil, Bayer, and Boehringer Ingelheim, and grant support from Ortho-McNeil, MediciNova, and Allergan; Dr. FitzGerald, receiving consulting fees from GlaxoSmithKline, lecture fees from Medtronic, and grant support from Pfizer; Dr. Lemack, receiving consulting fees from Pfizer and Allergan and lecture fees from Pfizer and Astellas and having equity interest in Pfizer; Dr. Johnson, receiving lecture fees from Johnson & Johnson; Dr. Stoddard, having equity in Johnson & Johnson, Bristol-Myers Squibb, Elan, and Procter & Gamble; Dr. Menefee, receiving grant support from Boston Scientific and having equity interest in Pfizer; Dr. Varner, receiving lecture fees from Pfizer; Dr. Moalli, receiving lecture fees from Boston Scientific that were contributed to a fellowship research fund; Dr. Steers, receiving consulting fees from Dynogen, Sanofi-Aventis, Astellas, and Allergan, lecture fees from Watson, Astellas, and GlaxoSmithKline Beecham, and grant support from Pfizer and having equity interest in Abbott and Johnson & Johnson. No other potential conflict of interest relevant to this article was reported.
© 2007 Massachusetts Medical Society. All rights reserved.