Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women

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.

Inclusion Criteria: * Female subject over 18 years of age at the time of consent signature * Subject with persistent severe urinary incontinence: * at least 3 months after failed pelvic floor muscle training OR * at least 6 months after a failed surgical treatment (e.g. slings) * Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test \> 100 grams * Subject willing and able to provide written informed consent and having signed the informed consent * 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 * Subject having a life expectancy ≥ 5 years as assessed by the investigator Exclusion Criteria: * 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 * Subject deprived of liberty by administrative or judicial decision or under legal guardianship * Subject who is unwilling or deemed by the investigator to be unwilling to comply with the clinical study requirements, including attending follow-up visits. * Subject having inadequate cognitive or capabilities to use the Artus device as assessed by the investigator * Pregnant subject, or subject willing to be pregnant during the study duration, or subject of child-bearing potential with non-stable medication contraception * Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy * Subject with overflow urinary incontinence * Subject with Significant Neuro-urological disorders: elevated detrusor pressure, Detrusor sphincter desinergy * Subject with history of pelvic radiotherapy * Subject with any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes * Subject with known allergy to any components of the device * Subject with history of Artificial Urinary Sphincter * Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy * 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 * Subject having a Body Mass Index (BMI) \> 40 * Subject with uncontrolled diabetes, defined as HbA1c \> 9.0% within the past 6 months * Subject with history of urethral fistula * Subject with history of bladder tumor * Subject with severe urethral stenosis. * Subject with currently active infection, including urinary tract infection * Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure * Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed * Subject with post void residual volume greater than 200 mL within the past 6 months * Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months * 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…)