12-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

To evaluate the safety and efficacy of the eCoin® - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after one year of treatment with the eCoin are presented.

A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at seven sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months post-activation, were compared to baseline values.

Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months, 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event.

The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Urology. 2021 May 25 [Epub ahead of print]

Peter Gilling, Patrick Meffan, Bilal Kaaki, Scott MacDiarmid, Vincent Lucente, Matthew Clark, Subhro K Sen, Sharon English, Peter K Sand

Tauranga Urology Research Ltd, Tauranga, New Zealand. Electronic address: ., Roundhay Medical Centre, Nelson, New Zealand., Unity Point Health, Waterloo, Iowa, USA., Alliance Urology Specialists, Greensboro, North Carolina, USA., Institute for Female Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania, USA., The Clark Center for Urogynecology, Newport Beach, California, USA., Stanford University, Stanford, California, USA., Canterbury Urology Research Trust, Christchurch, New Zealand., University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.