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PD24-15 SAFETY OF THE ECOIN IMPLANTABLE TIBIAL NERVE STIMULATOR - AN INTERIM ANALYSIS OF CLINICAL DATA AND REAL-WORLD EXPERIENCE
Abstract   Peer reviewed

PD24-15 SAFETY OF THE ECOIN IMPLANTABLE TIBIAL NERVE STIMULATOR - AN INTERIM ANALYSIS OF CLINICAL DATA AND REAL-WORLD EXPERIENCE

Anjali Kapur, Kathleen Kobashi, Craig Comiter, Dena Moskowitz, Andrea Pezzella, Kirk Redger, Annah Vollstedt, Larissa Rodriguez, John Kowalczyk, Christopher Smith, …
The Journal of urology, Vol.215(5S), p.e1349
05/2026
DOI: 10.1097/01.JU.0001191684.24295.39.15

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Abstract

INTRODUCTION AND OBJECTIVES: eCoin® is the first implantable tibial nerve stimulator (ITNS) FDA-approved for the treatment of urge urinary incontinence (UUI). It is leadless, implanted in the lower leg in the outpatient setting with local anesthesia, and delivers automatic stimulation over intermittent 30-minute sessions after activation. We report interim safety data for the eCoin ITNS (Valencia Technologies, Valencia, CA, USA) from clinical trial and real-world evidence. METHODS: Data was extracted from the RECIPE (Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation) study—a single-arm, prospective, multi-center study assessing 5-year safety and efficacy of eCoin after market approval. Interim safety data, evaluated by device- and procedure-related adverse events (AEs), was assessed at 42 months (3.5 years). Prospective real-world data was obtained from post-market surveillance of AEs from commercial cases over 13 months (January 2024-25). RESULTS: In the RECIPE study at 42 months, 155 patients met inclusion criteria and were implanted with eCoin. Subjects were mostly female (92.3%) and Caucasian (86.5%) with a mean age of 67.5 years (SD 11.3, 95% CI 65.7, 69.3). Implant site pain (9%) and urinary tract infection (11%) were the most reported AEs. Seven subjects underwent device explant (4.5%), of which 2 (1.3%) were procedure- or device-related: 1 (0.6%) for implant site cellulitis; 1 (0.6%) for site discomfort. Investigation of real-world data revealed 494 patients who received eCoin over 13 months. Twenty-seven patients (5.5%) underwent device explant, of which 2 (0.4%) were procedure- or device-related: 1 (0.2%) due to infection; 1 (0.2%) due to painful stimulation. Other reasons contributing to the overall explant rate in both cohorts were related to efficacy and physician/patient preference. These may be considered inappropriate explants as they were not device- or procedure-related issues. CONCLUSIONS: Real-world incidence of eCoin device explant due to procedure- or device-related AEs (infection, pain) is comparable to clinical trial incidence and is exceedingly low (<2%). This affirms the safety of the eCoin® ITNS device and procedure.

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