Clinical trial supported by RTI advances understanding of treatment options for mixed urinary incontinence in women

RTI served as the Data Coordinating Center (DCC) for the study, ensuring integrity and accuracy of data

RESEARCH TRIANGLE PARK, N.C. — A new study led by researchers at the University of Pennsylvania and RTI International, an independent scientific institute, found no significant difference in effectiveness between two treatments for mixed urinary incontinence (MUI) in women following a clinical trial across seven sites.

The study, published in the Journal of the American Medical Association (JAMA), compared midurethral sling surgery and onabotulinumtoxinA injections to determine if onabotulinumtoxinA was more effective at treating MUI, which includes both stress and urgency urinary incontinence.

“MUI is a common condition that can be challenging to treat,” said Dr. Heidi Harvie, M.D., MBA, MSCE, at the University of Pennsylvania. “For women who have failed conservative treatments for MUI, the benefits and order of approach of advanced bladder therapies have been unclear. The question is not only what procedural treatment improves MUI symptoms the most, but what is the best treatment to receive first, since many patients eventually pursue both. In this randomized study, participants had the option to cross over to the alternate treatment after six months.”

RTI served as the Data Coordinating Center for the study, with Marie Gantz, Ph.D., Senior Fellow at RTI as the principal investigator and RTI senior research statistician Sonia Thomas, Dr.P.H., as the lead statistician for the trial. The study was conducted through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network, a collaborative research initiative established in 2001 to advance the understanding and treatment of pelvic floor disorders in women.

The study involved 150 women aged 21 and older who had moderate to severe symptoms of both stress and urgency urinary incontinence and had not found relief with other treatments. The participants were enrolled between July 2020 and September 2022.

“As the Data Coordinating Center, we ensured that the data collected from multiple sites was meticulously managed and analyzed,” said Thomas. “This rigorous approach allowed us to deliver reliable and comprehensive results that can guide treatment decisions for mixed urinary incontinence."

Results showed that both treatments led to improvements in symptoms at six months, with no significant difference between the two groups. Women who received onabotulinumtoxinA injections saw an average improvement of 66.8 points on the Urogenital Distress Inventory total score, while those who had sling surgery saw an average improvement of 84.9 points. The difference between the two groups was not statistically significant.

The study also found that by 12 months, 30.3% of women in the sling group had received onabotulinumtoxinA injections, and 15.5% in the onabotulinumtoxinA group had received sling surgery, suggesting that many patients may eventually need both treatments to manage their symptoms effectively.

Read the full study via (JAMA)

Learn more about RTI’s coordinating center capabilities