[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642554":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":61,"collaborators":20,"id":63,"slug":20,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Myopowers Medical Technologies France SAS","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ARTUS","EXPERIMENTAL","The subjects will be implanted with the ARTUS Artificial Urinary Sphincter to treat Stress Urinary Incontinence",[13],"Device: Artificial Urinary Sphincter ARTUS",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Artificial Urinary Sphincter ARTUS","The subjects will be implanted by the ARTUS Artificial Urinary Sphincter (AUS). The device will be activated 6 weeks after surgery and the tightening will be adjusted by the investigators in order to reach continence.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Nicolas Barry Delongchamps, MD, PHD","Hôpital Cochin, APHP, Université Paris Cité, Paris, France.","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Jean-Christophe PERLES","CONTACT","+33 04 42 95 12 20","jcperles@carvolix.eu",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Federica Azzimonti","federica.azzimonti@carvolix.eu",[36,51],{"facility":37,"status":20,"city":38,"state":20,"zip":20,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Cochin Hospital, APHP","Paris","France",{"type":41,"coordinates":42},"Point",[43,44],2.3488,48.85341,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":49,"phoneExt":20,"email":50},"Nicolas Barry Delonghchamps, MD, PHD","+33 1 58 41 27 83","nicolas.barry-delongchamps@aphp.fr",{"facility":52,"status":20,"city":38,"state":20,"zip":20,"country":39,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Tenon Hospital, APHP",{"type":41,"coordinates":54},[43,44],{"lat":44,"lon":43},[57],{"name":58,"role":29,"phone":59,"phoneExt":20,"email":60},"Véronique Phé, MD, PHD","+33 01 56 01 70 00","veronique.phe@aphp.fr",{"type":62,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100642554",false,"NCT07641218","Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women","Pilot Clinical Investigation of the ARTUS® Artificial Urinary SPHincter (AUS) for the Treatment of Stress UrInary iNcontinence (SUI) in Women","SPHIN-X","Inclusion Criteria:\n\n* Female subject over 18 years of age at the time of consent signature\n* Subject with persistent severe urinary incontinence:\n\n  * at least 3 months after failed pelvic floor muscle training OR\n  * at least 6 months after a failed surgical treatment (e.g. slings)\n* Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \\> 100 grams\n* Subject willing and able to provide written informed consent and having signed the informed consent\n* Subject having understood and accepted to be unable to proceed to an MRI examination after the surgical procedure due to the non-MRI compatibility of the device\n* Subject having a life expectancy ≥ 5 years as assessed by the investigator\n\nExclusion Criteria:\n\n* Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period\n* Subject deprived of liberty by administrative or judicial decision or under legal guardianship\n* Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits.\n* Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator\n* Pregnant subject, or subject willing to be pregnant during the study duration, or subject of child-bearing potential with non-stable medication contraception\n* Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy\n* Subject with overflow urinary incontinence\n* Subject with Significant Neuro-urological disorders: elevated detrusor pressure, Detrusor sphincter desinergy\n* Subject with history of pelvic radiotherapy\n* Subject with any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes\n* Subject with known allergy to any components of the device\n* Subject with history of Artificial Urinary Sphincter\n* Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy\n* Subject under anti-coagulation or anti-platelet medication that cannot be discontinued at least 5 days prior to surgery and restarted at least 5 days after surgery\n* Subject having a Body Mass Index (BMI) \\> 40\n* Subject with uncontrolled diabetes, defined as HbA1c \\> 9.0% within the past 6 months\n* Subject with history of urethral fistula\n* Subject with history of bladder tumor\n* Subject with severe urethral stenosis.\n* Subject with currently active infection, including urinary tract infection\n* Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure\n* Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed\n* Subject with post void residual volume greater than 200 mL within the past 6 months\n* Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months\n* Subject in emergency situation (caused by a sudden life threatening or other sudden serious medical condition including but not limited to heart attack, stroke, coma, epileptic seizure, heavy bleeding, severe pain, trouble breathing…)","FEMALE","18 Years",{"count":73,"type":74},6,"ESTIMATED","INTERVENTIONAL",[77],"NA","The subjects will be implanted with the ARTUS® medical device and then be followed up to 2 years post-implantation, with the primary endpoints measured at 3-month post-implantation. Safety and Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.",[80],"Urinary Incontinence , Stress",[82,83,84,85],"Urinary Incontinence","Artificial Urinary Sphincter","Women","Stress Urinary Incontinence","NOT_YET_RECRUITING","2026-06-08",{"date":89,"type":90},"2026-06-11","ACTUAL",{"date":92,"type":74},"2026-06-30",{"date":94,"type":74},"2028-12-31",{"name":5,"class":6},2]