[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"UroMems SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100590540",false,"NCT06968741","A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)","Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men","SOPHIA2","Key Inclusion Criteria:\n\n* Male subjects aged ≥ 22 years old\n* Able to read, comprehend and willing to sign an informed consent form\n* Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator\n* Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator\n\nKey Exclusion Criteria:\n\n* Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent\n* Poor candidate for surgical procedures and\u002For anesthesia, as determined by investigator\n* Currently implanted with an Active Implantable Medical Device (AIMD)\n* Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator","MALE","22 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prospective, multicenter, single-arm study",[26],"Stress Urinary Incontinence (SUI)",[28,29],"Stress urinary incontinence","Artificial urinary sphincters","RECRUITING","2026-03-26",{"date":33,"type":34},"2026-03-27","ACTUAL",{"date":36,"type":34},"2025-05-19",{"date":38,"type":20},"2031-12",{"name":40,"class":41},"UroMems SAS","INDUSTRY",21,""]