PD66-01 TREATMENT OF URINARY URGENCY INCONTINENCE (UUI) WITH AN ULTRA-MINIATURIZED SACRAL NERVE MODULATION (SNM) SYSTEM: PRELIMINARY OUTCOMES OF THE SANS-UUI STUDY

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction III (PD66)1 Sep 2021PD66-01 TREATMENT OF URINARY URGENCY INCONTINENCE (UUI) WITH AN ULTRA-MINIATURIZED SACRAL NERVE MODULATION (SNM) SYSTEM: PRELIMINARY OUTCOMES OF THE SANS-UUI STUDY Osvaldo Padron, Craig Hanson, Rebecca McCrery, Stefan de Wachter, Bertil Blok, Alvero Lucioni, Jeffrey Mangel, Desiree Vrijens, Martijn Smit, Jeffery Verdoliva Boatman, Vollmer Mark, Alex Yeh, Andrina Hougham, and Steven Siegel Osvaldo PadronOsvaldo Padron More articles by this author , Craig HansonCraig Hanson More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , Stefan de WachterStefan de Wachter More articles by this author , Bertil BlokBertil Blok More articles by this author , Alvero LucioniAlvero Lucioni More articles by this author , Jeffrey MangelJeffrey Mangel More articles by this author , Desiree VrijensDesiree Vrijens More articles by this author , Martijn SmitMartijn Smit More articles by this author , Jeffery Verdoliva BoatmanJeffery Verdoliva Boatman More articles by this author , Vollmer MarkVollmer Mark More articles by this author , Alex YehAlex Yeh More articles by this author , Andrina HoughamAndrina Hougham More articles by this author , and Steven SiegelSteven Siegel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002110.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Treatment of UUI by SNM with an implantable pulse generator (IPG) and lead, with continuous 24/7 stimulation, has been standard of care for 20+ years. Neuspera’s battery-less ultra-miniaturized-IPG/lead (0.12cc), implanted in a single procedure, is wirelessly powered via an external device for short daily durations. The system has potential for reduced infection risk and complications associated traditional systems. Initial results of the SANS-UUI study. METHODS: The multi-center, open-label trial, included subjects with ≥6-month history of UUI and ≥4 UUI events on a 72-hour voiding diary. Subjects completed a 21-day trial period with 2-hours of daily stimulation. Subjects with <50% UUI reduction at 21 days increased stimulation to 4-hours for 14 days. All responders (≥50% UUI reduction) at end of trial (21 or 35 days) continued into the follow-up period. RESULTS: All 34 implanted subjects (94% women, mean age 62 yrs) completed trialing and ≥1-month follow-up, 33 subjects at 2 hrs and 1 at 4 hrs daily stimulation. All 34 subjects continue in the trial. Responder rate was statistically significant at end of trial, 1- and 3-months, Table 1. Reductions in baseline UUI (4.1 ± 2.0, mean ± SD) to end-of-trial, 1-, and 3-month visits were statistically significant (Table 1) and 29% of subjects were dry at 3 months. The ICIQ-OABqol total score significantly improved by 3X at 3 months (37.6 ± 21.2. mean ± SD, p<0.0001). Subjects stimulated 2.1 ± 0.6 hrs daily (mean ± SD) from implant to 3 months. Five subjects had <50% response at 1-month. All were responders at 3-months. There were 24 device / procedure related AEs in 11 subjects. Four surgical revisions occured: 2 lead dislodgements and 2 lead fractures. All 4 subjects restarted the trial phase, are included in Table 1 and were responders at last follow-up. One additional device fracture was reported in a subject with a previous fracture and revision with shorter implant model is pending. CONCLUSIONS: Using the Neuspera ultra-miniaturized SNM system 2 hrs / day is safe and effective with 85% and 95% of subjects with clinically and statistically significant improvements in UUI at 1 and 3 months, respectively and statistically significant improvements in QoL at 3 months. Source of Funding: Neuspera Medical © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1158-e1158 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Osvaldo Padron More articles by this author Craig Hanson More articles by this author Rebecca McCrery More articles by this author Stefan de Wachter More articles by this author Bertil Blok More articles by this author Alvero Lucioni More articles by this author Jeffrey Mangel More articles by this author Desiree Vrijens More articles by this author Martijn Smit More articles by this author Jeffery Verdoliva Boatman More articles by this author Vollmer Mark More articles by this author Alex Yeh More articles by this author Andrina Hougham More articles by this author Steven Siegel More articles by this author Expand All Advertisement Loading ...