Sling shows higher overall success, patient satisfaction than Burch

May 22, 2007

Two-year results of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) will allow physicians and patients to have more educated conversations about procedures for stress urinary incontinence and what can be expected in terms of efficacy and complications, according to the investigators of that prospective, randomized, National Institute of Diabetes and Digestive and Kidney Diseases-supported trial.

Two-year results of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) will allow physicians and patients to have more educated conversations about procedures for stress urinary incontinence and what can be expected in terms of efficacy and complications, according to the investigators of that prospective, randomized, National Institute of Diabetes and Digestive and Kidney Diseases-supported trial.

The results showed overall success was achieved by a significantly higher proportion of the sling patients compared with the Burch patients (47% vs. 38%; p=.01). Rates of stress incontinence-specific success were also significantly higher in the sling procedure than in the Burch procedure (66% vs. 49%; pp=.02).

Women were eligible to enroll in SISTEr if they had stress-predominant urinary incontinence symptoms, a positive cough/Valsalva stress test, urethral hypermobility on Q-tip exam, and desired surgical treatment for their incontinence. A total of 655 women were randomized, of whom 79% had complete data at the 2-year visit.

Safety evaluations showed that morbidity was lower among women who underwent Burch colposuspension. Compared with the women who underwent the Burch procedure, women in the sling group had more urinary tract infections (299 vs. 202 events) along with higher rates of voiding dysfunction (14% vs. 2%, pp=.04).

"The SISTEr trial demonstrates that rigorous clinical trials designed to provide the highest levels of evidence can be conducted successfully. In cooperation with our patients and continued support from the NIDDK, we can use this as a model for evaluating other types of therapies that are currently available," said co-author Michael Albo, MD, University of California at San Diego.

"For the first time, we have a meticulous, relatively long-term comparison of these common surgeries in women," added Leroy M. Nyberg Jr, MD, PhD, of the NIDDK. "Women who participated in this study have made it possible for many women with stress incontinence and their doctors to make more-informed choices based on clear benefits, risks, and personal preferences."

The study will appear in the May 24 edition of the New England Journal of Medicine. For an audio interview with Dr. Albo, please tune into www.urologytimes.com/radio_AUA2007.