LBA01-05 PIVOTAL STUDY OF A NOVEL WIRELESSLY POWERED, PATIENT TAILORED PROGRAMMED, TIBIAL NEUROSTIMULATOR FOR THE TREATMENT OF PATIENTS WITH OVERACTIVE BLADDER

Abstract

You have accessJournal of UrologyCME1 Apr 2023LBA01-05 PIVOTAL STUDY OF A NOVEL WIRELESSLY POWERED, PATIENT TAILORED PROGRAMMED, TIBIAL NEUROSTIMULATOR FOR THE TREATMENT OF PATIENTS WITH OVERACTIVE BLADDER John Heesakkers, Alessandro Digesu, Suzette Sutherland, Osvaldo Padron, Cindy Amundsen, Rebecca McCrery, Emily Kean, Kevin Benson, Kevin Cline, Kaiser Robertson, Felicia Lane, Frank Martens, Stefan De Wachter, Kimberley Ferrante, Laura Giusto, Roger Dmochowski, and Philip Toozs-Hobson John HeesakkersJohn Heesakkers More articles by this author , Alessandro DigesuAlessandro Digesu More articles by this author , Suzette SutherlandSuzette Sutherland More articles by this author , Osvaldo PadronOsvaldo Padron More articles by this author , Cindy AmundsenCindy Amundsen More articles by this author , Rebecca McCreryRebecca McCrery More articles by this author , Emily KeanEmily Kean More articles by this author , Kevin BensonKevin Benson More articles by this author , Kevin ClineKevin Cline More articles by this author , Kaiser RobertsonKaiser Robertson More articles by this author , Felicia LaneFelicia Lane More articles by this author , Frank MartensFrank Martens More articles by this author , Stefan De WachterStefan De Wachter More articles by this author , Kimberley FerranteKimberley Ferrante More articles by this author , Laura GiustoLaura Giusto More articles by this author , Roger DmochowskiRoger Dmochowski More articles by this author , and Philip Toozs-HobsonPhilip Toozs-Hobson More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003360.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The BlueWind Medical Device is a novel miniature, leadless, battery-less, sub-facially implantable tibial neuromodulation system. The implant is wirelessly powered and modulated by an external wearable unit. A Clinician Programmer is used to individually tailor stimulation parameters (i.e., frequency, pulse width and amplitude). A pivotal trial was conducted to evaluate the safety and efficacy of the BlueWind Medical Device for treating Urge Urinary Incontinence (UUI) in women. METHODS: One hundred and fifty-one women with UUI were enrolled in 23 centers in the United States and Europe, for this prospective, single arm, open-label study. Inclusion criteria required at least 9 UUI episodes during a 7-day diary. The device was activated ∼4 weeks after implantation, and the patients performed daily stimulation treatments at home for ∼30 minutes twice daily. Stimulation parameters were individually tailored according to a predefined algorithm per patient sensation and response. Multiple Treatment Programs were provided for patients when needed. Voiding diaries, quality of life and patient satisfaction questionnaires were collected at 6 and 12 months after device activation. The primary safety measure was incidence of Adverse Events (AE) at 12 months post activation. Primary efficacy end point was defined as ≥50% reduction in UUI episodes compared to baseline. RESULTS: One hundred and fifty-one subjects, mean age 58.8 (SD: 12.5) were implanted. The subjects demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Results are presented based on the intend to treat analysis set with 144 and 140 patients reaching 6- and 12-months post activation, respectively. No device or procedure related Serious Adverse Events (SAE) were reported by 12 months. At 6 and 12 months, 76.4% and 78.4% of the subjects were therapy responders (p<.0001), respectively, with 50% of the subjects dry at 12 months (on 3 consecutive days diary). At 12 months, 84.6% of the patients showed ≥10 points improvement (Minimal Important Difference; MID) in Health Related Quality of Life (p<.0001). CONCLUSIONS: The BlueWind Medical Device has demonstrated an excellent safety profile with no device or procedure related SAEs. Efficacy endpoints were met with high proportion of dry patients, high compliance, and high patient satisfaction. Source of Funding: BlueWind Medical is the Sponsor of OASIS trial © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1178 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Heesakkers More articles by this author Alessandro Digesu More articles by this author Suzette Sutherland More articles by this author Osvaldo Padron More articles by this author Cindy Amundsen More articles by this author Rebecca McCrery More articles by this author Emily Kean More articles by this author Kevin Benson More articles by this author Kevin Cline More articles by this author Kaiser Robertson More articles by this author Felicia Lane More articles by this author Frank Martens More articles by this author Stefan De Wachter More articles by this author Kimberley Ferrante More articles by this author Laura Giusto More articles by this author Roger Dmochowski More articles by this author Philip Toozs-Hobson More articles by this author Expand All Advertisement PDF downloadLoading ...