Two-Year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence.

To evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence in patients with overactive bladder.The one-year pivotal study was extended through two years. The ITNS is a novel and recently FDA-approved therapy. A prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory urgency urinary incontinence to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the overactive bladder questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of urgency urinary incontinence episodes. The primary safety measure was device-related adverse events. 72 subjects completed the 96-week evaluation. 78% (95% CI: 67% - 87%) experienced at least 50% reduction in urgency urinary incontinence episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their urgency urinary incontinence episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. 91.3% did not require additional medications for overactive bladder. No serious or unanticipated adverse events were reported in this extension phase. The eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating overactive bladder patients with urgency urinary incontinence. The findings support it as an excellent treatment option for refractory patients.

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interest 1) Dr Vincent Lucente: Paid consultant to Sponsor; Study Investigator Funded by Sponsor; Stock Holder for Valencia Technologies 2) Dr Laura Giusto: Financial Relationship to Competitors-Proctor for Bluewind; Primary Investigator of Medtronic TITAN trial 3) Dr Scott MacDiarmid: Paid consultant to Sponsor; Study Investigator Funded by Sponsor; Stock Holder for Valencia Technologies