PD21-03 EFFICACY OF A COIN-SIZED TIBIAL NEUROSTIMULATOR FOR URGENCY URINARY INCONTINENCE: INTERIM PIVOTAL RESULTS

INTRODUCTION AND OBJECTIVE: Existing options for refractory overactive bladder (OAB) treatment lack appeal to most patients given invasiveness or delivery of therapy, or require significant patient compliance and burden on the provider. A novel, subcutaneously implanted tibial neurostimulator (eCoin) has the potential to address such drawbacks while providing a significant clinical benefit. Presented are interim results from the eCoin-2 pivotal trial, a prospective, multi-center single-arm study evaluating the safety and efficacy of eCoin in treating urgency urinary incontinence (UUI) after 24 weeks. METHODS: At 15 U.S. sites, 133 subjects were implanted with eCoin in the medial lower leg during an office procedure under local anesthesia. We included men and women ages 18-80 with at least one daily UUI episode on a 3-day voiding diary. Subjects were washed off OAB medications prior to baseline. The leadless, primary battery-powered eCoin device is slightly larger than a U.S. nickel and delivers automated therapy every 3-4 days for 30 minutes. The primary efficacy variable is the proportion of subjects achieving ≥50% improvement in UUI episodes (responder rate) after 48 weeks of therapy. Secondary outcomes included 3-day voiding diary data and patient reported outcomes. Paired t-tests were used to compare continuous variables between baseline and 24 weeks with differences reported with 95% confidence intervals. RESULTS: At baseline in all subjects, average age (SD) was 64 (11), BMI was 30.4 (8.8), daily UUI episodes was 4.2 (3.1), and the OABq-SF symptom bother score was 65.7 (20.0). 98.5% of subjects were female. The average procedure time was 20.8 minutes. There was one related serious adverse event, a localized infection resolved by device explant. In 113 subjects available at 24 weeks, all measures showed statistically significant improvement: UUI leaks were reduced by -2.7 (p<0.001, 95%CI (-3.2,-2.1)) and the symptom bother score was improved by 32.6 (p<0.001, 95%CI (-37.6, -27.6)). The responder rate was 70.8%, and 77.8% of patients reported feeling at least better on the PGI-I. In patients with ≥10 daily voids at baseline (n=58), frequency improved by -1.9 (p<0.001, (-2.6, -1.1)) from 12.7 mean voids. CONCLUSIONS: The interim data demonstrates that eCoin is safe and effective in treating UUI, delivering meaningful symptom improvement with minimal invasiveness. The eCoin procedure also appears to have a short learning curve and is an easy to perform office-based procedure. Source of Funding: Research was funded by Valencia Technologies.