Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence

Abstract

Objective: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A followon trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation.Methods: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline.Results: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study. Conclusions:The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder

“…ITNS requires a stimulator to be implanted into the tibial nerve, which induces similar side‐effects as PTNS. The clinical benefits of implanting eCoin® (Valencia Technologies Corp., Valencia, CA, USA) for treating OAB have been well demonstrated [15–17]. However, its beneficial effect has not been validated in multicentre clinical randomised studies.…”

“…The clinical benefits of implanting eCoin â (Valencia Technologies Corp., Valencia, CA, USA) for treating OAB have been well demonstrated [15][16][17]. However, its beneficial effect has not been validated in multicentre clinical randomised studies.…”