[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642554":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":62,"collaborators":20,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":20,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"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",[36,52],{"facility":37,"status":20,"city":38,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Cochin Hospital, APHP","Paris","France","FR",{"type":42,"coordinates":43},"Point",[44,45],2.3488,48.85341,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":20,"email":51},"Nicolas Barry Delonghchamps, MD, PHD","+33 1 58 41 27 83","nicolas.barry-delongchamps@aphp.fr",{"facility":53,"status":20,"city":38,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Tenon Hospital, APHP",{"type":42,"coordinates":55},[44,45],{"lat":45,"lon":44},[58],{"name":59,"role":29,"phone":60,"phoneExt":20,"email":61},"Véronique Phé, MD, PHD","+33 01 56 01 70 00","veronique.phe@aphp.fr",{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100642554","pilot-study-of-the-artus-artificial-urinary-sphincter-on-women-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":75,"type":76},6,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Urinary Incontinence , Stress",[84,85,86,87],"Urinary Incontinence","Artificial Urinary Sphincter","Women","Stress Urinary Incontinence","NOT_YET_RECRUITING","2026-06-08",{"date":91,"type":92},"2026-06-11","ACTUAL",{"date":94,"type":76},"2026-06-30",{"date":96,"type":76},"2028-12-31",{"name":5,"class":6},2]