Urologic Diseases Research Updates
Fall 2007

Sling Surgery More Effective than Burch Technique for Female Bladder Control

The largest and most rigorous U.S. clinical study of two operations for stress urinary incontinence (SUI) in women found the sling procedure helps more women achieve bladder control than the Burch technique, according to the National Institutes of Health (NIH).

The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) found that significantly more women with a sling made from a patient’s own tissue and placed around the urethra for extra support were dry, compared with women with a Burch colposuspension, in which sutures are attached to a pelvic ligament to support the urethra.

Two years after surgery, 47 percent of women who had the sling procedure and 38 percent who had the Burch technique remained dry from leakage caused by stress or, possibly, urge incontinence. For stress-specific leakage only, 66 percent of women with a sling and 49 percent with a Burch procedure remained dry.

Stress incontinence is when coughing, laughing, sneezing, running, or lifting heavy objects causes urine to leak from the bladder. Urge incontinence is the sudden feeling of the need or urge to urinate. The most common cause of urge incontinence is inappropriate bladder contractions.

SISTEr randomized 655 women with either pure SUI or a combination of stress and urge incontinence to receive a fascial sling or the Burch procedure. Complete information on the measures used to assess urinary incontinence was available for 520 participants—79 percent—2 years after surgery. The study also accounted for quality of life issues, patient satisfaction, and side effects.

While most women in the study were satisfied with the treatment results, those who received a sling were significantly more satisfied—86� percent compared with 78� percent of the Burch group.

However, positive results of the procedure were tempered by side effects, which were more common among women with slings. The most common side effect was urinary tract infection, which occurred in 63 percent of women who had a sling and 47 percent who had the Burch procedure.

Fourteen percent of women with a sling versus 2 percent of women with the Burch procedure also had more voiding problems, and 27 percent versus 20 percent had persistent urge incontinence. Nineteen women with slings who had difficulty voiding after treatment needed surgery to correct the problem; no one in the Burch group needed corrective surgery for voiding problems.

Urinary incontinence is a common and costly condition that reduces quality of life. According to the National Institute of Diabetes and Digestive and Kidney Diseases’ (NIDDK) Urologic Diseases in America project, up to 75�percent of U.S. women have some degree of incontinence, costing $12.4 billion in 1995.

SUI is commonly treated with surgery to support the bladder neck and urethra. Randomized, controlled trials comparing these operations are rare. Studies predating SISTEr were small, short-term, or less stringent about diagnostic criteria and outcome measures, producing inconsistent results across studies. SISTEr set a higher bar by standardizing definitions, clinical evaluations, and surgical procedures at all sites and by using “composite outcome measures and a more rigid definition of success compared with other studies,” according to the study’s authors.

This higher bar may account for lower success rates in SISTEr than in earlier trials, but it also “establishes a template for conducting surgical trials for urinary incontinence and for other urological conditions,” said John W. Kusek, Ph.D., the NIDDK’s co-director of kidney and urology trials.

SISTEr defined two levels of treatment success. Stress-specific success required that women have no leakage symptoms during physical activities, no leakage during a cough stress-test and valsalva—a maneuver performed by forcibly exhaling against closed lips and pinched nose—and no re-treatment for the problem. Overall success required that women meet SUI-specific treatment goals, have a negative pad test, and have no leakage episodes recorded on a 3-day voiding diary.

“For the first time, we have a meticulous, relatively long-term comparison of these common surgeries in women,” said Leroy M. Nyberg Jr., Ph.D., M.D., director of urology research at 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 NIDDK, the National Institute of Child Health and Human Development, and the Office of Research on Women’s Health at the NIH funded the Urinary Incontinence Treatment Network (UITN), a group of nine clinical centers and a biostatistical center, to conduct a series of rigorous, long-term trials of common incontinence therapies. SISTEr is the first trial completed by the UITN, with two other studies in the wings.

Results of the second trial, the Behavior Enhances Drug Reduction of Incontinence, a study for urge incontinence, are expected later this year. The third study, the Trial of Mid-Urethral Slings, is recruiting patients to compare two minimally invasive surgeries for the treatment of SUI. For more information about the UITN, visit www.uitn.net. For a copy of What I need to know about Bladder Control, visit www.kidney.niddk.nih.gov/kudiseases/pubs/bcw_ez.

Results of the SISTEr study appeared in the May� 24 issue of the New England Journal of Medicine.

NIH Publication No. 08–5743
November 2007

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