The Stress Incontinence Surgical Treatment Efficacy Trial

Among women with urinary incontinence, 50 to 80% are identified as having stress urinary incontinence (SUI), or involuntary leakage of urine resulting from physical exertion, sneezing, or coughing. The Burch colposuspension and the autologous rectus fascial sling are two surgical procedures frequently used to treat SUI. Both procedures are believed to have similar “cure” rates, yet have not been compared directly to each other in a large, randomized clinical trial. The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) is a multicenter, randomized study that was conducted to compare the efficacy and safety of the sling and Burch procedures. Complications, quality of life, sexual function, patient satisfaction, costs, and the need for additional treatments or surgery were also compared for the two procedures as secondary objectives.

Women with documented symptoms of SUI for at least 3 months and a positive standardized urinary stress test who were planning to undergo surgery as treatment were enrolled and randomly assigned in the operating room to either a sling or Burch procedure. Key elements of the two surgical procedures were standardized among all clinical centers and participating surgeons. Data were collected preoperatively and postoperatively and included information on demographics, risk factors for urinary incontinence, clinical characteristics of urinary incontinence, findings on physical examination, and urodynamic evaluation. The two primary outcome measures consisted of composite measures of success of treatment in both overall urinary incontinence and specific stress incontinence.

Results showed that the pubovaginal fascial sling had significantly higher rates of success for both overall and stress-specific incontinence than did the Burch colposuspension in women with predominant SI at 24 months. Additionally, the frequency of surgical retreatment for SI was greater in the Burch group than in the sling group, although these higher success rates were offset by increased morbidity in the sling group.

Data from the E-SISTEr 5 year follow-up are now included in the data package.