LBA-06 12 MONTH FEASIBILITY DATA OF A FULLY-IMPLANTED, NICKEL-SIZED AND SHAPED TIBIAL NERVE STIMULATOR FOR THE TREATMENT OF OVERACTIVE BLADDER SYNDROME WITH URGENCY URINARY INCONTINENCE

Le résumé fourni par la source

You have accessJournal of UrologySunday Next Frontier (LBA)1 Apr 2019LBA-06 12 MONTH FEASIBILITY DATA OF A FULLY-IMPLANTED, NICKEL-SIZED AND SHAPED TIBIAL NERVE STIMULATOR FOR THE TREATMENT OF OVERACTIVE BLADDER SYNDROME WITH URGENCY URINARY INCONTINENCE Scott MacDiarmid*, Vincent Lucente, Bilal Kaaki, Sharon English, Peter Gilling, Patrick Meffan, Matthew Clark, Peter Sand, Subhro Sen, and Eric Rovner Scott MacDiarmid*Scott 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 , Peter GillingPeter Gilling More articles by this author , Patrick MeffanPatrick Meffan More articles by this author , Matthew ClarkMatthew Clark More articles by this author , Peter SandPeter Sand More articles by this author , Subhro SenSubhro Sen More articles by this author , and Eric RovnerEric Rovner More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557498.26013.2eAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: The eCoin® (Electroceutical Coin) (Valencia Technologies Corp., Valencia, CA, USA) is an investigational, implanted, battery-powered, slightly larger than a United States nickel in diameter (23.3 mm versus 21.2 mm) and thickness (2.4 mm versus 1.95 mm), neuromodulation device for the treatment of overactive bladder syndrome (OAB) with urgency urinary incontinence (UUI) in adults who have an inadequate response to or are intolerant of OAB medications by electrically stimulating the tibial nerve. The device can be implanted during an office-based procedure under local anesthesia, and does not require external stimulation. This was a 12 month clinical feasibility trial to evaluate the long-term safety and efficacy of eCoin® tibial nerve stimulation to treat refractory UUI. METHODS: The long-term (12 month) study was a prospective, single-arm, open-label study including 46 participants with refractory UUI, conducted at multiple sites in the US and New Zealand. The eCoin® was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6 and 12 months post-activation, were compared to baseline. RESULTS: Mean age was 63.4 ± 11.5 years and 45 participants were female. Episodes of UUI were reduced by a median 68% after 12 months of treatment (4.2 versus 1.7 episodes/day at 12 months; p=.001). Overall, 30/46 participants (65%) experienced more than a 50% improvement in UUI. Of those participants, 8 experienced ≥ 75% improvement and 12 experienced 100% improvement. Incontinence quality of life (I-QOL) scores improved by a mean of 86%. A single serious adverse event, secondary to the provided ankle wrap, resolved with intravenous antibiotics. CONCLUSIONS: The implantable eCoin® neuromodulation device showed durable efficacy and safety through 12 months and is a promising new treatment option for refractory OAB. Source of Funding: Valencia Technologies Corp. Greensboro, NC; Allentown, PA; Waterloo, IA; Christchurch, New Zealand; Tauranga, New Zealand; Nelson, New Zealand; Newport Beach, CA; Skokie, IL; Redwood City, CA; Charleston, SC© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e994-e994 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor 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 Peter Gilling More articles by this author Patrick Meffan More articles by this author Matthew Clark More articles by this author Peter Sand More articles by this author Subhro Sen More articles by this author Eric Rovner More articles by this author Expand All Advertisement PDF downloadLoading ...

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.