MP75-18 SAFETY & EFFICACY OF THE ECOIN™ IMPLANTABLE TIBIAL NERVE STIMULATION DEVICE FOR OVERACTIVE BLADDER SYNDROME

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You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy III1 Apr 2018MP75-18 SAFETY & EFFICACY OF THE ECOIN™ IMPLANTABLE TIBIAL NERVE STIMULATION DEVICE FOR OVERACTIVE BLADDER SYNDROME Scott MacDiarmid, Vincent Lucente, Bilal Kaaki, Sharon English, Patrick Meffan, Peter Gilling, Matthew Clark, Subhro Sen, and Peter Sand Scott MacDiarmidScott MacDiarmid More articles by this author , Vincent LucenteVincent Lucente More articles by this author , Bilal KaakiBilal Kaaki More articles by this author , Sharon EnglishSharon English More articles by this author , Patrick MeffanPatrick Meffan More articles by this author , Peter GillingPeter Gilling More articles by this author , Matthew ClarkMatthew Clark More articles by this author , Subhro SenSubhro Sen More articles by this author , and Peter SandPeter Sand More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2110AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES This is a preliminary report of a prospective, multicenter 12 week study of the novel implantable eCoin™ system for posterior tibial nerve stimulation that evaluated changes from baseline in overactive bladder syndrome (OAB) symptoms on voiding diaries and patient reported outcomes after 8 and 12 weeks of treatment . METHODS 46 subjects were implanted with the eCoin™ device over the posterior tibial nerve at baseline (Figure) and then automatically treated for 30 minute sessions. Subjects completed 3-day bladder diaries to assess change in voiding symptoms at 4, 8 & 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. The eCoin™ system is implanted subcutaneously over the tibial nerve in the lower leg under local anesthesia. RESULTS Nineteen of the 46 subjects have completed the 8 week follow-up to date. One woman did not meet the inclusion criteria and was excluded. At 2 months (N=19) there was a 73% reduction in urgency urinary incontinence (UUI)/day from 4.54±3.28 to 1.39 or a reduction by 3.15±2.96 UUI/day and at 3 months (N=5) there was a 88% reduction from 3.33±0.97 to 0.46 or a reduction of 2.87±0.77 UUI/ day. At two months, 75% of subjects (N=19) had ≥50% improvement in UUI, 60% had ≥75% improvement, and 35% had 100% improvement. At two months, 70% of subjects (N=19) reported iQoL score improvements ≥10 as did 100% of subjects (N=5) at three months. Two serious adverse events (one unrelated pneumonia and one related blister from ankle support) have occurred. CONCLUSIONS These preliminary data, showing a marked improvement in UUI and quality of life at the 8 week assessment, suggest great promise for eCoin stimulation of the posterior tibial nerve. Data from the full sample (N=46) will provide additional information about the efficacy of the eCoin™ system. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1015-e1016 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Scott MacDiarmid More articles by this author Vincent Lucente More articles by this author Bilal Kaaki More articles by this author Sharon English More articles by this author Patrick Meffan More articles by this author Peter Gilling More articles by this author Matthew Clark More articles by this author Subhro Sen More articles by this author Peter Sand More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

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