MP18-10 EVALUATION OF CLINICAL PERFORMANCE AND SAFETY FOR THE RECHARGEABLE INTERSTIM TM MICRO IN OVERACTIVE BLADDER SUBJECTS: 3-MONTH RESULTS FROM THE GLOBAL POST-MARKET ELITE STUDY

Le résumé fourni par la source

You have accessJournal of UrologyCME1 May 2022MP18-10 EVALUATION OF CLINICAL PERFORMANCE AND SAFETY FOR THE RECHARGEABLE INTERSTIMTM MICRO IN OVERACTIVE BLADDER SUBJECTS: 3-MONTH RESULTS FROM THE GLOBAL POST-MARKET ELITE STUDY Keith Xavier, Colin Goudelocke, Barry Pecha, Kimberly Burgess, Marie-Aimée Perrouin-Verbe, Ryan Krlin, Jodi Michaels, Sagar Shah, Benoît Peyronnet, Stanley Zaslau, Bianca Papi, Katie Bittner, Dean Elterman, and Victor Nitti Keith XavierKeith Xavier More articles by this author , Colin GoudelockeColin Goudelocke More articles by this author , Barry PechaBarry Pecha More articles by this author , Kimberly BurgessKimberly Burgess More articles by this author , Marie-Aimée Perrouin-VerbeMarie-Aimée Perrouin-Verbe More articles by this author , Ryan KrlinRyan Krlin More articles by this author , Jodi MichaelsJodi Michaels More articles by this author , Sagar ShahSagar Shah More articles by this author , Benoît PeyronnetBenoît Peyronnet More articles by this author , Stanley ZaslauStanley Zaslau More articles by this author , Bianca PapiBianca Papi More articles by this author , Katie BittnerKatie Bittner More articles by this author , Dean EltermanDean Elterman More articles by this author , and Victor NittiVictor Nitti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002551.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Sacral Neuromodulation (SNM) is an established advanced therapy for treatment of symptoms of overactive bladder, nonobstructive urinary retention, and fecal incontinence supported by studies with long-term follow up. The ELITE study is an ongoing global, prospective, post-market study to confirm the clinical performance and safety of the InterStimTM Micro SNM system in all indicated conditions. METHODS: Eligible subjects with symptoms of OAB (greater than or equal to 8 urgency frequency episodes per day and/or 3 or more episodes of urinary urge incontinence on a 3-day voiding diary) were enrolled in the OAB cohort following successful therapy evaluation and neurostimulator implant. Subjects completed voiding diaries and questionnaires at baseline and 3-month follow up. Safety was evaluated by collection of reportable adverse events (AE). Data are reported as mean ± standard deviation or with 95% confidence intervals (CI). RESULTS: Subjects enrolled in the OAB cohort (n=68) had a primary diagnosis of UUI (22%), UF (7%), or both UUI and UF (71%). Most subjects were female (89.7%). The mean age was 62±13 years and BMI was 32±7 kg/m2. At baseline UUI subjects (n=63) had 6.0±4.5 leaks per day and UF subjects (n=53) had 14±6.5 voids per day. At the 3-month follow up, the average change in leaks per day was -4.0 (95% CI: -4.7, -2.6) for UUI subjects (n=62) and average change in voids per day was -5.0 (95% CI: -6.3, -2.7) for UF subjects (n=62). The average degree of urgency was 2 ± 0.5 for UUI subjects and 2 ± 0.6 for UF subjects at baseline on a 0-4 scale. At 3-month follow up, urgency was 1.4 ± 0.6 and 1.4 ± 0.7 for UUI and UF subjects, respectively. The incidence of device-, procedure-, or therapy- related AEs in enrolled subjects was 2.9% (2/68) and serious AEs was 1.5% (1/68) at the time of database snapshot. There were no unanticipated adverse device effects. CONCLUSIONS: The change in symptoms is consistent with previous reports and rate of adverse events is favorable compared to previously reported rates for SNM thereby confirming the safety and clinical performance of InterStimTM Micro for subjects with OAB. These data add to the established SNM evidence with data from the rechargeable InterStimTM Micro. Source of Funding: Medtronic © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e299 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Keith Xavier More articles by this author Colin Goudelocke More articles by this author Barry Pecha More articles by this author Kimberly Burgess More articles by this author Marie-Aimée Perrouin-Verbe More articles by this author Ryan Krlin More articles by this author Jodi Michaels More articles by this author Sagar Shah More articles by this author Benoît Peyronnet More articles by this author Stanley Zaslau More articles by this author Bianca Papi More articles by this author Katie Bittner More articles by this author Dean Elterman More articles by this author Victor Nitti 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.