The New England Journal of Medicine, 2007, Vol.356(21), pp.2143-2155
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. (ClinicalTrials.gov number, NCT00064662 .) This multicenter, randomized clinical trial compared two surgical procedures — the Burch colposuspension and the autologous fascial pubovaginal sling — in women with urinary stress incontinence. Success rates (in terms of overall urinary-incontinence measures and stress-incontinence measures specifically) were higher at 2 years for the sling group, but this group also had greater morbidity. These findings inform decision making with respect to surgical treatment of stress incontinence and underscore the importance of surgical randomized trials. This trial compared two surgical procedures — the Burch colposuspension and the fascial sling — in women with urinary stress incontinence. Success rates were higher at 2 years for the sling group, but this group also had greater morbidity. Urinary incontinence affects an estimated 15 to 50% of women,1,2 resulting in a significant medical, social, and economic burden.1 In 1995 dollars, the annual direct costs of incontinence in the United States were estimated to be more than $16 billion.3 Among women with incontinence, 50 to 80% are identified as having stress incontinence,4 or involuntary leakage of urine resulting from physical exertion or sneezing and coughing.5 Although the initial treatment of stress incontinence is often nonsurgical (behavioral therapy, pelvic-floor exercises, or incontinence devices), surgical treatment is considered for patients who are bothered by persistent symptoms. An estimated 4 to . . .
Postoperative Complications -- Epidemiology ; Urinary Incontinence, Stress -- Surgery ; Urologic Surgical Procedures -- Methods;