Sacral neuromodulation, botulinum show equal efficacy

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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.

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Christopher J. Chermansky, MD“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.

Next: ROSETTA results

ROSETTA results

A total of 381 women were randomized to either sacral neuromodulation or intradetrusor injection of botulinum toxin, 200 U. As previously reported, there was a greater reduction at 6 months in the mean number of daily UUI episodes favoring the botulinum toxin group (−3.9 vs. −3.3 episodes per day; p=.01).

In the follow-up report presented at the ICS meeting, which included 24-month follow-up data for 293 of the women enrolled in ROSETTA, there was no difference in mean number of daily UUI episodes at 24 months (−3.9 episodes per day for botulinum toxin vs. −3.5 episodes per day for sacral neuromodulation, p=.15).

Although complete resolution and >75% reduction of UUI episodes was more commonly seen in the botulinum toxin group at 6 months, this difference was not maintained over 24 months. Yet, the botulinum toxin group had higher satisfaction and treatment endorsement scores sustained to 24 months (mean difference of −9.2 for treatment satisfaction and −11.2 for treatment endorsement on the Overactive Bladder Satisfaction of Treatment questionnaire).

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Among the women receiving botulinum toxin, 72% requested a second injection, and the clean intermittent catheterization rate was 6%. Also, the UTI rate at 24 months was 18% in the botulinum toxin group, compared with 8% for sacral neuromodulation (p≤.05). Sacral neuromodulation revision and removals occurred in 3% and 9%, respectively. Additionally, 58% of these patients required at least one reprogramming, and only 17% required three or more reprogrammings.

Researchers aren’t sure what could account for the higher satisfaction and treatment endorsement rates in the botulinum toxin arm, though one possibility is the long interval between botulinum toxin injections at the 200-unit dose.

“If they are coming in on average just once a year for their repeat injection, there may be satisfaction with that,” Dr. Chermansky said.

Dr. Chermansky is a clinical trial study site principal investigator for Allergan.