The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)

General Description

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.

Objectives

The primary objective of the SISTEr study was to compare the efficacy and safety of the Burch colposuspension and the autologous rectus fascial sling procedures as treatment for stress urinary incontinence in women. 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.

Outcome Measure

The two primary outcome measures consisted of composite measures of success in both overall urinary-incontinence and specific stress-incontinence measures. Overall treatment success was defined as no self-reported symptoms of urinary incontinence, an increase of less than 15 g in pad weight during a 24-hour pad test, no incontinence episodes recorded in a 3-day diary, a negative urinary stress test (no leakage noted on examination during cough and Valsalva maneuvers at a standardized bladder volume of 300 ml), and no retreatment for urinary incontinence (including behavioral, pharmacologic, and surgical therapies). Treatment success specific to stress incontinence was defined as no self-reported symptoms of stress incontinence, a negative stress test, and no retreatment for stress incontinence.

Criteria

Women who exhibited symptoms of predominant stress urinary incontinence for at least 3 months by self-report and examination, had a positive urinary stress test, and who were eligible for both surgical procedures were eligible for enrollment.

Exclusion criteria are documented in the study protocol.

Outcome

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. However, these higher success rates were offset by greater morbidity, such as urinary tract infection, urge incontinence, and voiding dysfunction. The frequency of surgical retreatment for SI was greater in the Burch group than in the sling group.