Study compares treatments for urinary incontinence in women
In a study appearing in the JAMA, Cindy L. Amundsen, M.D., of Duke University, Durham, N.C., and colleagues assessed whether injection of on a botulinum toxin A (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 on a botulinum toxin A 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 on a botulinum toxin A (n = 192) or sacral neuromodulation (n = 189). Of the 364 women (average age, 63 years) in the intention-to-treat population, 190 in the on a botulinum toxin A 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 on a botulinum toxin A 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. On a botulinum toxin A did increase the risk of urinary tract infections and need for self-catheterizations.
"Overall, these findings make it uncertain whether on a botulinum toxin A provides a clinically important net benefit compared with sacral neuromodulation," the authors write.