For many women coughing, laughing, sneezing, running or lifting heavy objects causes urine to leak, a condition commonly known as stress urinary incontinence. Among women with incontinence, 50 to 80 percent have stress urinary incontinence.

May 21, 2007

BIRMINGHAM, Ala. - For many women coughing, laughing, sneezing, running or lifting heavy objects causes urine to leak, a condition commonly known as stress urinary incontinence. Among women with incontinence, 50 to 80 percent have stress urinary incontinence.

In the largest, most rigorous U.S. trial of two traditional operations for stress urinary incontinence in women a team of urologists and urogynecologists, including University of Alabama at Birmingham (UAB) urogynecologist Holly E. Richter, Ph.D., M.D., found that an autologous fascial sling procedure is significantly more effective than the Burch technique.

The study is being released early by the New England Journal of Medicine (NEJM) to coincide with a presentation at the annual meeting of the American Urological Association on May 21. Results will appear in the May 24 print edition of NEJM.

The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) found that an autologous rectus fascia sling is significantly more successful than the Burch colposuspension technique for treating both overall urinary incontinence and stress-specific incontinence.  

In the autologous sling procedure, a harvested strip of rectus fascia is placed transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures. In the Burch modified colposuspension, the anterior vaginal wall is suspended at the level of the bladder neck with permanent sutures tied to the iliopectineal ligament.

Two years after surgery, overall success rates were 47 percent and 38 percent for the sling and Burch groups, respectively. Success rates in stress incontinence alone rose to 66 percent and 49 percent for sling and Burch, respectively. These outcomes were based on a combination of both subjective and objective measures, not just one or two as in most previous studies.

"For the first time, we have a rigorous, relatively long-term comparison of these traditional surgeries," Richter said. "These two procedures have been considered the gold standards of surgical treatment for urinary incontinence for many years. Not only does the information provided by this trial enable women with stress incontinence and their doctors to make more-informed choices based on clear benefits and risks and personal preferences, but because it is the most robust randomized trial, this study lays the ground work for future research trials for stress urinary incontinence in women."

SISTEr randomized 655 women to assess whether a rectus fascial sling or a Burch colposuspension was more effective for bladder control overall and for stress incontinence specifically. Primary outcomes data were available for 520, or 79 percent, of participants at 24 months. Secondary outcomes assessed quality of life, patient satisfaction and side effects.

While all women in the study were highly satisfied with the treatment they received, those with a sling were significantly more satisfied. Eighty-six percent with a sling were satisfied, compared to 78 percent of the Burch group. 

Side effects were more common among women with slings, tempering the positive results of the procedure. The most common side effect was urinary tract infections, which occurred in 63 percent of women undergoing a sling procedure and 47 percent of the Burch group. Women with a sling also had more voiding problems (14 percent versus 2 percent) and persistent urge incontinence, the loss of urine just before feeling a strong, sudden urge to empty the bladder, (27 percent versus 20 percent).

The National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development and Office of Research on Women's Health funded the trial.

Other authors on the paper are: Michael E. Albo, M.D., University of California, San Diego; Linda Brubaker, M.D., University Medical Center, Maywood, Ill.; Peggy Norton, M.D., University of Utah Health Sciences Center; Stephen R. Kraus, M.D., University of Texas Health Sciences Center; Philippe E. Zimmern, M.D., University of Texas Southwestern; Toby C. Chai, M.D., University of Maryland;  Halina Zyczynski, M.D., Magee Women's Hospital, University of Pittsburgh; Ananias C. Diokno, M.D., Beaumont Hospital Medical Center, Royal Oak, Mich.; Sharon Tennstedt, Ph.D., New England Research Institutes, Watertown, Mass.; Charles Nager, M.D., University of California, San Diego; L. Keith Lloyd, M.D., UAB; MaryPat FitzGerald, M.D., University Medical Center; Gary E. Lemack, M.D., University of Texas Southwestern; Harry W. Johnson, M.D., University of Maryland; Wendy Leng, M.D., Magee Women's Hospital; Veronica Mallett, M.D., Oakwood Hospital, Dearborn, Mich.; Anne M. Stoddard, Sc.D., New England Research Institutes; Shawn Menefee, M.D., University of California, San Diego; R. Edward Varner, M.D., UAB; Kimberly Kenton, M.D., University Medical Center; Pam Moalli, M.D., Magee Women's Hospital; Larry Sirls, M.D., Beaumont Hospital Medical Center; Kimberly J. Dandreo, M.Sc., New England Research Institutes; John W. Kusek, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases; Leroy M. Nyberg, M.D., Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases; and William Steers, M.D., University of Virginia Health Systems, for the Urinary Incontinence Treatment Network.