Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women (SPHIN-X)

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…)