PD21-03 EFFICACY OF A COIN-SIZED TIBIAL NEUROSTIMULATOR FOR URGENCY URINARY INCONTINENCE: INTERIM PIVOTAL RESULTS
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Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- PD21-03 EFFICACY OF A COIN-SIZED TIBIAL NEUROSTIMULATOR FOR URGENCY URINARY INCONTINENCE: INTERIM PIVOTAL RESULTS
- Date Crossref
- 01/04/2020
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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University of Nebraska at Omaha pays non établi dans la noticeUniversité ou école supérieure
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University of Nebraska at Omaha, Norwalk Hospital et Columbia College - South Carolina, avec 9 autres affiliations.
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