RESEARCH TRIANGLE PARK, N.C. — Two new studies in women suffering from pelvic floor disorders such as urinary incontinence and vaginal prolapse find that surgery may be beneficial. One study found that in women with two types of urinary incontinence, surgery improves outcomes, contrasting with current treatment guidelines. Another study found that women with mesh implants have similar outcomes to hysterectomy for vaginal prolapse repair. The studies were sponsored by the National Institutes of Health and published in JAMA. RTI functioned as the Data Coordinating Center for both studies.
“We are pleased that RTI has had the opportunity to contribute to such impactful research,” said Marie Gantz, PhD, a senior research statistician at RTI and Principle Investigator of the Pelvic Floor Disorders Network Data Coordinating Center. “It has been exciting to collaborate with NICHD and the network’s clinical centers to provide important information to women and their health care providers on treatment options for pelvic floor disorders.”
The first study, ESTEEM, investigated treatments for a combination of stress urinary incontinence (leaking that occurs with a cough or sneeze) and urgency urinary incontinence. Mid-urethral sling, a well-established surgery for stress urinary incontinence, was found to improve symptoms in women who have both types. The findings challenge current treatment guidelines, which suggest that the surgery may worsen urgency urinary incontinence in women with both forms, also called mixed urinary incontinence.
The second study, SUPeR, found that two surgical procedures used to correct vaginal prolapse—one to remove the uterus and one that supports the uterus with mesh—have comparable three-year outcomes. Traditionally, surgeons treat vaginal prolapse, caused by weakening of the support muscles, with a procedure that requires a hysterectomy. The other procedure instead uses mesh to suspend the uterus and pelvic organs so they no longer fall out of place. However, the U.S. Food and Drug Administration halted the sale of mesh kits for vaginal prolapse repair in April 2019 for safety reasons. To date, this randomized clinical trial provides the longest-term comparison of the procedures. More long-term research is needed to determine if one procedure is better than the other, and researchers will continue to follow the patients for a total of five years.
Both studies were funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Office of Research on Women’s Health and appear in the September 17th issue of the Journal of the American Medical Association.