Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial.

A novel leadless tibial nerve stimulator (LTNS) provides a primary battery-powered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome (OAB) therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this investigational device, called eCoin® (Valencia Technologies Corporation, Valencia, CA, USA) for treating refractory urgency urinary incontinence (UUI).

This was a prospective, open-label, single-arm trial carried out at 15 US medical centers involving 137 subjects with refractory UUI. After implantation in the lower leg above the fascia over the tibial nerve, eCoin delivered automated stimulation sessions for the duration of the study. The primary efficacy measure was the proportion of subjects who achieved a 50% or greater reduction from baseline in UUI episodes after 48 weeks of therapy. The primary safety measure was device-related adverse events at the same time point.

Of 137 subjects enrolled, 133 were implanted with eCoin, and 132 were included in the intention-to-treat (ITT) population. Of those 132 subjects, 98% were female, mean (SD) age was 63.9 (10.9), and mean (SD) baseline daily UUI episodes was 4.3 (3.1). The primary efficacy analysis showed 68% (95% CI: 60%-76%) of subjects experienced at least a 50% reduction in UUI episodes at 48-weeks post-activation. Sixteen percent (16%) of implanted subjects experienced device-related events through 52 weeks post-implantation.

eCoin demonstrated clinical benefit for treating OAB with automatic delivery of an intermittent low-duty cycle and implanted with a minimally-invasive, brief procedure.

The Journal of urology. 2021 Apr 02 [Epub ahead of print]

Alexandra Rogers, Stephanie Bragg, Kimberly Ferrante, Chuladatta Thenuwara, David K L Peterson

Department of Urology, Sansum Clinic, Santa Barbara, California., Statistics Collaborative, Inc., Washington, District of Columbia., Department of Urogynecology, Kaiser Permanente Point Loma, San Diego, California., Valencia Technologies Corporation, Valencia, California.