protocolSection identificationModule nctId: NCT06345677, orgStudyIdInfo id: ViXe-CLP-0002, briefTitle: Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects, acronym: XAVIER, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-09, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Vensica Therapeutics Ltd., class: INDUSTRY, collaborators name: Blueclinical, Ltd., descriptionModule briefSummary: The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit., conditionsModule conditions: Overactive Bladder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: ViXe Xombination, interventions name: Placebo + Sham, outcomesModule primaryOutcomes measure: Adverse Events Rate, primaryOutcomes measure: Usability and ease-of-use perception by investigator, subject and technician, secondaryOutcomes measure: Daily Urgency Urinary Incontinence, secondaryOutcomes measure: Total Daily Episodes, secondaryOutcomes measure: Urinary Urgency, secondaryOutcomes measure: Voiding Leaks, secondaryOutcomes measure: Quality of Life Queationnsaire, secondaryOutcomes measure: Nocturia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHUC, city: Coimbra, country: Portugal, geoPoint lat: 40.20564, lon: -8.41955, locations facility: HSOG, city: Guimarães, country: Portugal, geoPoint lat: 41.44443, lon: -8.29619, locations facility: CHLN, city: Lisboa, country: Portugal, geoPoint lat: 38.71667, lon: -9.13333, locations facility: CHUSJ, city: Porto, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Hospital Lusíadas, city: Porto, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Hospital Prelada, city: Porto, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Hospital Luz Setúbal, city: Setúbal, country: Portugal, geoPoint lat: 38.5244, lon: -8.8882, locations facility: CHVNG, city: Vila Nova De Gaia, country: Portugal, geoPoint lat: 41.13363, lon: -8.61742, hasResults: False