To address the shortcomings associated with typical PTNS therapy, Scott MacDiarmid, MD, of Alliance Urology Specialists and the University of North Carolina, Chapel Hill, presented a preliminary report of a prospective, multicenter 12-week study of the novel implantable eCoin™ system (Valencia Technologies, Valencia, CA) for PTNS delivery. To assess outcomes, changes from baseline in overactive bladder syndrome (OAB) symptoms on voiding diaries and patient-reported outcomes were collected after 8 and 12 weeks of treatment.
The eCoin™ implant is a battery-powered leadless titanium device about the size of a nickel (23 mm in diameter and 2.2 mm thick) that can be programmed to delivery PTNS treatment at home. It has an amplitude range of 0.5 to 25mA, with a rate of 20 pulses per second and a pulse width of 0.2 ms. The implantation can be performed in the clinic and typically takes 15 minutes. The device is placed through a 3 cm incision along the posterior tibial nerve (see figure). The incision is allowed to heal for 2-4 weeks, then activated at 1 month. Patients then undergo 30-minute PTNS every 2 days for the first 3 months, then require maintenance every 15 days. The battery reportedly last 3 years.
46 subjects (mean age 63.4 years) were implanted with the eCoin™ device subcutaneously over the tibial nerve in the lower leg under local anesthesia. They were then treated for 30-minute stimulation sessions, and subjects completed 3-day bladder diaries to assess change in voiding symptoms at 4, 8 and 12 weeks from baseline. Quality of life was also assessed with the Incontinence Quality of Life instrument (iQOL). Safety was evaluated by reported adverse events.
38 of the 46 participants reported had 8 week follow-up, and 22 subjects had follow-ups of 12 weeks. Mean change in urinary urgency incontinence (UUI) episodes per day was -4.27±3.12 with a mean baseline of 5.46±3.27 at 3 months. At 3 months, 18/22 (82%) subjects reported that they are “better” (23%), “much better” (8%), or “very much better” (50%), and 4/22 (18%) reported feeling the “same.” 32% reported no UUI following treatment with the device.
Two serious adverse events occurred; pneumonia occurred in one subject and was deemed unrelated to the procedure, while another had an infected blister from the ankle support, which required explantation of the device. There were no reports of device migration or infection of the device.
Based on the preliminary data reported, the eCoin™ implant appeared to show a marked improvement in UUI and quality of life at the 12-week assessment, suggesting a potential means to deliver PTNS at home. However, larger scale studies with longer term follow-up is necessary to compare the eCoin™ device to traditional PTNS in safety and efficacy
Presented by: Scott MacDiarmid, MD, Alliance Urology Specialists, University of North Carolina, Chapel Hill, NC
Co-Authors: Vincent Lucente, Allentown, PA, Matthew Clark, Newport Beach, CA, Bilal Kaaki, Waterloo, IA, Sharon English, Christchurch, New Zealand, Peter Gilling, Tauranga, New Zealand, Patrick Meffan, Nelson, New Zealand, Peter Sand, Evanstown, IL, Subhro Sen, Stanford, CA
Written by: Judy Choi, MD, Assistant Professor, Department of Urology, University of California, Irvine @judymchoi at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA