Anjali Kapur, MD, highlights post-market safety data on eCoin ITNS for UUI

In the following video, Anjali Kapur, MD, discusses early results from a post-market analysis of the safety of the eCoin implantable tibial nerve stimulator for patients with urge urinary incontinence (UUI). The results, which span both clinical findings and real-world experience data, were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2026 Winter Meeting in San Juan, Puerto Rico.¹

Kapur is a urogynecologist and reconstructive pelvic surgeon at Hackensack Meridian Health in central New Jersey.

The RECIPE (Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation) study is an ongoing, prospective, multicenter, single-arm trial evaluating long-term safety and efficacy of the eCoin device over 5 years. The interim analysis included 155 patients in the registry (assessed at 42 months), alongside 494 patients treated in routine clinical practice (assessed at over 13 months). According to Kapur, the primary objective was to determine whether the safety profile observed in a regulated trial environment would be maintained in broader, real-world use, with safety assessed by device- and procedure-related adverse events and device explant rates.

The analysis reported that overall explant rates were comparable between the 2 cohorts, at approximately 5%. In the RECIPE study, 4.5% of patients underwent explant, while 5.5% of patients in the real-world cohort required device removal. Importantly, the proportion of explants attributed to device- or procedure-related complications—such as infection or pain—was low in both settings, occurring in fewer than 2% of patients. The most commonly reported adverse events in the RECIPE trial cohort included implant site pain (9%) and urinary tract infection (11%), findings that were consistent with expectations for this patient population and procedure type.

According to the authors, these interim findings suggest that the safety profile of the eCoin ITNS in a real-world setting is comparable to that in a clinical trial. The low rate of device- or procedure-related adverse events across both datasets supports the tolerability of the therapy and reinforces confidence in its use for patients with UUI, although continued follow-up from the RECIPE study will be important to confirm long-term outcomes.

REFERENCE

1. Kapur A, Pezzella A, Moskowitz D, et al. SAFETY OF THE ECOIN® IMPLANTABLE TIBIAL NERVE STIMULATOR – AN INTERIM ANALYSIS OF CLINICAL DATA AND REAL-WORLD EXPERIENCE. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2026 Winter Meeting. February 25-28, 2026. San Juan, Puerto Rico. Abstract OM09