In patients with refractory urgency urinary incontinence (UUI), sacral neuromodulation (InterStim) and onabotulinumtoxinA (Botox) produce similar reductions in mean daily UUI episodes, according to 24-month follow-up data on patients treated in a randomized trial.
Investigators in the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial in 2016 reported that botulinum toxin at 6 months of treatment resulted in a “small daily improvement in UUI episodes” that was statistically significant (JAMA 2016; 316:1366–74).
Now, in long-term follow-up data on ROSETTA, NIH investigators reported at the International Continence Society annual meeting in Florence, Italy that the two treatments provide similar reductions in mean daily UUI episodes at 24 months. However, botulinum toxin treatment was more likely to provide complete resolution of episodes 6 months after treatment, and it was associated with higher patient satisfaction and treatment endorsement ratings over the 24 months, reported first author Christopher J. Chermansky, MD, assistant professor of urology at the University of Pittsburgh School of Medicine.
“Even though the primary outcome was the same with respect to UUI episode reduction, there was this difference in treatment satisfaction and treatment endorsement that favored botulinum toxin over sacral neuromodulation,” Dr. Chermansky told Urology Times.
As previously reported in 6-month ROSETTA results, botulinum toxin was associated with higher rates of urinary tract infection, while sacral neuromodulation required revisions and removals in some patients.
“At this point, we have two equally efficacious treatments,” Dr. Chermansky said.
As the prevalence of UUI increases in an aging population, so does the use of third-line treatment options, including botulinum toxin, sacral neuromodulation, and percutaneous tibial nerve stimulation, when more conservative measures do not provide relief. However, little data exist to guide treatment choice in third-line therapies. In one systematic review, researchers found that current evidence was insufficient to recommend one treatment over another (Evid Rep Technol Assess 2009; 187:1-120).
Subsequently, ROSETTA investigators used a comparative effectiveness design to assess whether botulinum toxin was superior to sacral neuromodulation in reducing UUI episodes in women with symptoms refractory to conservative measures.