[{"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:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100590540","a-study-to-assess-the-safety-and-effectiveness-of-the-uroactive-artificial-urinary-sphincter-aus-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":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, multicenter, single-arm study",[27],"Stress Urinary Incontinence (SUI)",[29,30],"Stress urinary incontinence","Artificial urinary sphincters","RECRUITING","2026-03-26",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":35},"2025-05-19",{"date":39,"type":21},"2031-12",{"name":41,"class":42},"UroMems SAS","INDUSTRY",21,""]