[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Myopowers Medical Technologies France SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Urinary Incontinence , Stress",[29,30,31,32],"Urinary Incontinence","Artificial Urinary Sphincter","Women","Stress Urinary Incontinence","NOT_YET_RECRUITING","2026-06-08",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":21},"2026-06-30",{"date":41,"type":21},"2028-12-31",{"name":43,"class":44},"Myopowers Medical Technologies France SAS","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100425993","safety-and-clinical-performance-study-of-the-artus-artificial-urinary-sphincter-aus-100425993","NCT04827199","Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)","Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency","DRY","Inclusion Criteria:\n\n1. Male subject between 18 and 80 years (inclusive) of age at the time of consent signature\n2. Subject with persistent urinary incontinence, defined as \\>12 months\n3. Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \\> 75 grams\n4. Subject willing and able to provide written informed consent\n5. Subject willing and able to comply with all clinical study requirements, including the ability to independently operate the device remote control\n6. Subject willing and able to comply with follow-up visits\n7. 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\n8. Subject having signed the informed consent\n\nExclusion Criteria:\n\n1. Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms\n2. Subject with history of Artificial Urinary Sphincter or male sling implantation\n3. Subject with history of pelvic radiotherapy\n4. Subject with history of Artificial Urinary Sphincter-related urethral erosion\n5. Subject with history of urethral fistula\n6. Subject with history of bladder tumour\n7. Subject with severe urethral stenosis\n8. Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy\n9. Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy\n10. 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\n11. Subject with currently active infection, including urinary tract infection\n12. Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure\n13. Subject with a current vesicourethral reflux\n14. Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed\n15. Subject with bladder or urethral foreign body or calculus\n16. Subject with allergy to any components of the device\n17. Subject deprived of liberty by administrative or judicial decision or under legal guardianship\n18. Subject having a Body Mass Index (BMI) \\> 40\n19. Subject with post void residual volume greater than 200 mL, within the past 6 months\n20. Subject with uncontrolled diabetes, defined as HbA1c \\> 9.0%, within the past 6 months\n21. Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months\n22. 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\n23. Subject who underwent any surgical procedure in the last 3 months, or with planned surgical procedure within the next 3 months\n24. Subject who is unwilling or deemed by the Investigator to be unwilling to comply with the Clinical Investigation Plan, or subject with a history of non-compliance\n25. Subject unable to understand and sign the ICF in absence of legal representative\n26. Subject with a lack of capacity to consent\n27. Subject unable to read and write\n28. Subject in emergency situation","MALE","80 Years",{"count":56,"type":21},70,[24],"This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.\n\nThe study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:\n\n* pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites),\n* pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety),\n* long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).\n\nThe objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.",[32],[30],"2022-09-14",{"date":63,"type":37},"2022-09-19",{"date":65,"type":21},"2022-12",{"date":67,"type":21},"2034-12",{"name":43,"class":44},3,""]