Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence

Abstract

BackgroundWe conducted a clinical feasibility trial to evaluate the safety and efficacy of a fully-implanted, primary battery-powered, nickel-sized and shaped neuromodulation device called the eCoinTM (Valencia Technologies Corp., Valencia, CA, USA) for tibial nerve stimulation to treat refractory urgency urinary incontinence. MethodsThis was a prospective, single-arm, open-label study including 46 participants with refractory UUI, conducted at multiple sites in the US and New Zealand. The eCoinTM was implanted 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 and 6 months post-activation, were compared to baseline. ResultsMean age was 63.4 ± 11.5 years and 45 (98%) participants were female. Episodes of urgency urinary incontinence were reduced by a median 71% after 3 months of treatment (4.2 versus 1.7 daily episodes at 3 months; P=.001). A ≥50% reduction in reported episodes of urgency urinary incontinence was observed in 32/46 participants (69.6%) at 3 months with more than 20% of participants dry at 3 and at 6 months. Incontinence quality of life (I-QOL) scores improved by an average of 25.9 points, and 33/46 patients (72%) indicated improvement in symptoms. A single serious adverse event, secondary to wound care, resolved with intravenous antibiotics. ConclusionsThe implantable neuromodulation device was a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or resolution of symptoms and no significant safety concerns.