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June 7, 2010
Surgeries Equally Effective for Women’s Bladder Control
Two common operations for bladder control problems in women had similar success rates but slightly different side effects, a large clinical trial found. The results could help patients and doctors make better-informed decisions about surgical treatments for stress urinary incontinence.
Urinary incontinence is common in women and often leads to poorer quality of life. Women with stress urinary incontinence leak urine when coughing, laughing, sneezing, running or lifting heavy objects. The symptoms sometimes resolve even without treatment. But women with persistent and bothersome incontinence often choose surgery to restore bladder control.
NIH is funding a series of multisite clinical trials to compare different urinary incontinence therapies for women. These studies are supported by NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health. The first completed trial compared 2 types of surgery that require abdominal incisions and relatively long postoperative recovery times (read more in NIH Research Matters).
The new study compared 2 common types of procedures known as midurethral-sling surgeries. Both are minimally invasive and often performed on an outpatient basis with rapid recovery times. Both involve the use of a synthetic mesh material, or sling, that acts as a hammock to support the urethra and prevent leakage.
The scientists randomly assigned nearly 600 women with stress urinary incontinence to receive either a retropubic sling or a transobturator sling. A retropublic sling passes under the urethra and behind the pubic bones in the pelvis. A transobturator sling passes under the urethra and out through the upper inner thigh or groin area.
As reported in the June 3, 2010, issue of the New England Journal of Medicine, both groups had equivalent levels of treatment success. When tested a year after surgery, about 80% in each group achieved dryness. In surveys, 62% of the women in the retropubic group and 56% in the transobturator group reported achieving dryness, a small difference between the 2 groups that could have occurred by chance.
The risks and side effects of the 2 procedures differed. Overall, serious adverse events were more common in the retropubic group (14%) than in the transobturator group (6%). The retropubic group had more bladder perforations during surgery and serious bladder-emptying problems that had to be fixed surgically, as well as a slightly greater likelihood of post-surgery urinary tract infections. The transobturator group had more vaginal perforations during surgery and neurological problems, such as upper leg weakness.
"This rigorous, large-scale, comparative effectiveness trial represents a major milestone in treatment for stress urinary incontinence, an underdiagnosed public health problem affecting millions of American women," says NIDDK Director Dr. Griffin P. Rodgers. "Investments in this kind of research enable women and their doctors to weigh more accurately the benefits and risks of available treatment options."