Plenary: Next Frontier, Sunday, Afternoon Session
Presentation Authors: Scott MacDiarmid*, Greensboro, NC, Vincent Lucente, Allentown, PA, Bilal Kaaki, Waterloo, IA, Sharon English, Christchurch, New Zealand, Peter Gilling, Tauranga, New Zealand, Patrick Meffan, Nelson, New Zealand, Matthew Clark, Newport Beach, CA, Peter Sand, Skokie, IL, Subhro Sen, Redwood City, CA, Eric Rovner, Charleston, SC
Introduction: The eCoin® (Electroceutical Coin) (Valencia Technologies Corp., Valencia, CA, USA) is an investigational, implanted, battery-powered, slightly larger than a United States nickel in diameter (23.3 mm versus 21.2 mm) and thickness (2.4 mm versus 1.95 mm), neuromodulation device for the treatment of overactive bladder syndrome (OAB) with urgency urinary incontinence (UUI) in adults who have an inadequate response to or are intolerant of OAB medications by electrically stimulating the tibial nerve. The device can be implanted during an office-based procedure under local anesthesia, and does not require external stimulation.
This was a 12 month clinical feasibility trial to evaluate the long-term safety and efficacy of eCoin® tibial nerve stimulation to treat refractory UUI.
Methods: The long-term (12 month) study 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 eCoin® 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, 6 and 12 months post-activation, were compared to baseline.
Results: Mean age was 63.4 ± 11.5 years and 45 participants were female. Episodes of UUI were reduced by a median 68% after 12 months of treatment (4.2 versus 1.7 episodes/day at 12 months; p=.001). Overall, 30/46 participants (65%) experienced more than a 50% improvement in UUI. Of those participants, 8 experienced ≥ 75% improvement and 12 experienced 100% improvement. Incontinence quality of life (I-QOL) scores improved by a mean of 86%. A single serious adverse event, secondary to the provided ankle wrap, resolved with intravenous antibiotics.
Conclusions: The implantable eCoin® neuromodulation device showed durable efficacy and safety through 12 months and is a promising new treatment option for refractory OAB
Source of Funding: Valencia Technologies Corp.