Secondary Logo

Journal Logo

Urodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (PD06): Podium 6: Friday, September 10, 2021

PD06-09 PATIENT EXPERIENCE WITH A LEADLESS TIBIAL NERVE STIMULATOR FOR URGENCY URINARY INCONTINENCE

Rogers, Alexandra; McCrery, Rebecca; Lukban, James; MacDiarmid, Scott; Sen, Subhro; Lukban, James; Kaaki, Bilal; Shapiro, Andrew; Guidice, Thomas; Nguyen, John; Gauta, Joseph; Serels, Scott; Threatt, Chris; Kaminetsky, Jed; Lucente, Vincent; Dutta, Sonia; Sand, Peter; Ferrante, Kimberly

doi: 10.1097/JU.0000000000001974.09
  • Free

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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).

F1

Source of Funding:

Valencia Technologies

© 2021 by American Urological Association Education and Research, Inc.