INTRODUCTION AND OBJECTIVE:
Third line therapies for refractory overactive bladder (OAB) undertreat patients with only 5% of patients progressing to these invasive and/or burdensome therapies (Du et al.).A novel leadless, fully-implantable tibial nerve stimulator has unique attributes compared to current OAB treatments including automated compliance, a brief procedure using only local anesthetic and reliance on minimal resources. Patient experience with this device (eCoin®) was evaluated after 48 weeks of therapy.
A prospective, multi-center, single-arm trial was conducted to evaluate the eCoin in treatment of refractory urgency urinary incontinence (UUI). The device is slightly larger than a United States nickel and is implanted subcutaneously in the medial lower leg during an office procedure under local anesthetic, and once activated delivers automated 30-minute therapy sessions every 3-4 days. After 48 weeks of therapy, subjects were queried in a survey about their satisfaction and experience with the device and procedure and their attitudes about the study device as it compares to other therapies.
Of the 132 subjects in the intent-to-treat population, 98% were female, mean (SD) age was 63.9 (10.9), and mean (SD) baseline UUI daily episodes was 4.3 (3.1). The primary efficacy analysis showed 68% (95% CI: 60%, 76%) of subjects experienced at least a 50% reduction in UUI episodes at 48 weeks. Patient experience is in line with efficacy results. 89% indicated they would recommend eCoin to friends and family with overactive bladder, and 93% indicated the procedure was easy enough to go through every five years. When directly compared to other OAB treatments, patients chose eCoin over OAB medications (84%), percutaneous tibial nerve stimulation (80%), onabotulinumtoxinA (74%), and sacral neuromodulation (82%). See the figure for response proportions.
The data shows this maintenance-free device with a brief and minimally invasive implantation is well tolerated by patients. Compared to sacral neuromodulation (SNM), in which a recent study on the human experience with SNM surgery demonstrated 50% of subjects post IPG placement would not recommend the surgery to friend/family, eCoin may more effectively penetrate as a third line therapy for refractory UUI (Cohen et. al).
Source of Funding: