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

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (PD06)1 Sep 2021PD06-09 PATIENT EXPERIENCE WITH A LEADLESS TIBIAL NERVE STIMULATOR FOR URGENCY URINARY INCONTINENCE Alexandra Rogers, Rebecca McCrery, James Lukban, Scott MacDiarmid, Subhro Sen, James Lukban, Bilal Kaaki, Andrew Shapiro, Thomas Guidice, John Nguyen, Joseph Gauta, Scott Serels, Chris Threatt, Jed Kaminetsky, Vincent Lucente, Sonia Dutta, Peter Sand, and Kimberly Ferrante Alexandra RogersAlexandra Rogers More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , James LukbanJames Lukban More articles by this author , Scott MacDiarmidScott MacDiarmid More articles by this author , Subhro SenSubhro Sen More articles by this author , James LukbanJames Lukban More articles by this author , Bilal KaakiBilal Kaaki More articles by this author , Andrew ShapiroAndrew Shapiro More articles by this author , Thomas GuidiceThomas Guidice More articles by this author , John NguyenJohn Nguyen More articles by this author , Joseph GautaJoseph Gauta More articles by this author , Scott SerelsScott Serels More articles by this author , Chris ThreattChris Threatt More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , Vincent LucenteVincent Lucente More articles by this author , Sonia DuttaSonia Dutta More articles by this author , Peter SandPeter Sand More articles by this author , and Kimberly FerranteKimberly Ferrante More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001974.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract 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). Source of Funding: Valencia Technologies © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e103-e103 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alexandra Rogers More articles by this author Rebecca McCrery More articles by this author James Lukban More articles by this author Scott MacDiarmid More articles by this author Subhro Sen More articles by this author James Lukban More articles by this author Bilal Kaaki More articles by this author Andrew Shapiro More articles by this author Thomas Guidice More articles by this author John Nguyen More articles by this author Joseph Gauta More articles by this author Scott Serels More articles by this author Chris Threatt More articles by this author Jed Kaminetsky More articles by this author Vincent Lucente More articles by this author Sonia Dutta More articles by this author Peter Sand More articles by this author Kimberly Ferrante More articles by this author Expand All Advertisement Loading ...