In a study appearing in JAMA, Cindy L. Amundsen, M.D., of Duke University, Durham, N.C., and colleagues assessed whether injection of onabotulinumtoxinA (Botox A) is superior to sacral neuromodulation (use of an implanted electrode for bladder control) in controlling episodes of refractory urgency urinary incontinence in women.
Urgency urinary incontinence is a sudden need to void resulting in uncontrollable urine loss. This disruptive condition is common and increases with age, from 17 percent of women older than 45 years to 27 percent older than 75 years in the United States. Women with refractory (not responsive to treatment) urgency urinary incontinence are treated with onabotulinumtoxinA and sacral neuromodulation (involves the implantation of a small electrode tip near the sacral nerve, which controls voiding function in the lower spine; the implanted device stimulates the nerve to act as a sort of pacemaker for the bladder) with limited comparative information.
For this study, conducted at nine U.S. medical centers, the researchers randomly assigned women with refractory urgency urinary incontinence to an injection of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Of the 364 women (average age, 63 years) in the intention-to-treat population, 190 in the onabotulinumtoxinA group had a statistically significant greater reduction in 6-month average number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day). Participants treated with onabotulinumtoxinA showed greater improvement in an overactive bladder questionnaire for symptom bother, treatment satisfaction and treatment endorsement than treatment with sacral neuromodulation.
However, there was no significant difference for quality of life or for measures of treatment preference, convenience, or adverse effects. OnabotulinumtoxinA did increase the risk of urinary tract infections and need for self-catheterizations.
"Overall, these findings make it uncertain whether onabotulinumtoxinA provides a clinically important net benefit compared with sacral neuromodulation," the authors write.
Article: OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women, Cindy L. Amundsen MD, Holly E. Richter PhD, MD, Shawn A. Menefee MD, Yuko M. Komesu MD, Lily A. Arya MD, MS, W. Thomas Gregory MD, Deborah L. Myers MD, Halina M. Zyczynski MD, Sandip Vasavada MD, Tracy L. Nolen DrPH, Dennis Wallace PhD, Susan F. Meikle MD, MSPH, JAMA, doi:10.1001/jama.2016.14617, published 4 October 2016.
This work was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIH Office of Research on Women's Health at National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, etc.