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).
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.
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