protocolSection identificationModule nctId: NCT06283498, orgStudyIdInfo id: DO612574A, briefTitle: Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: InMode MD Ltd., class: INDUSTRY, descriptionModule briefSummary: The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladderThe main questions it aims to answer are:•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\]Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment., conditionsModule conditions: Overactive Bladder Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Device Morpheus8V, outcomesModule primaryOutcomes measure: Change in urgency incontinence episodes after 3 month, secondaryOutcomes measure: Change in urgency incontinence episodes after 1 month, secondaryOutcomes measure: Change in urgency incontinence episodes, secondaryOutcomes measure: Change in urgency incontinence episodes, secondaryOutcomes measure: Analysis to assess the urinary frequency, secondaryOutcomes measure: Analysis to assess urinary frequency, secondaryOutcomes measure: Analysis to assess the urinary frequency., secondaryOutcomes measure: Analysis to assess the urinary frequency., secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Assessment of the impact of the treatment on Overactive Bladder symptoms, secondaryOutcomes measure: Patient-reported Pain assessment, secondaryOutcomes measure: Patient-reported outcome measure, secondaryOutcomes measure: Patient-reported outcome measure, secondaryOutcomes measure: Patient-reported outcome measure, secondaryOutcomes measure: Patient-reported outcome measure, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mickey Karram MD, city: Corona Del Mar, state: California, zip: 92625, country: United States, geoPoint lat: 33.59808, lon: -117.87311, locations facility: Institute for Female Pelvic Medicine, city: Knoxville, state: Tennessee, zip: 37932, country: United States, geoPoint lat: 35.96064, lon: -83.92074, hasResults: False