Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men

Exclusion Criteria

• •Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study within 3 months
• •Vulnerable patient (patient deprived of their liberty due to a judicial or administrative decision, patient suffering from psychiatry troubles preventing him from giving his consent, patients hospitalized for reason other than the current clinical investigation, patient under 18 years of age, patient under tutelage, patient having withdrawn his consent)
• •Patients whom the investigator determines to be poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
• •Patient presenting one or several contraindications of the device
• •Any planned procedure requiring urethral catheterization 12 months after implant procedure (include intermittent catheterization) except for diagnostic purposes
• •Known allergy to UroMems eAUS implantable components
• •Known allergy to intravenous iodine
• •Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards, unless further investigation confirms the absence of primary prostate cancer or local recurrence assessed by investigator.
• •Uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of \>12 mmol/l (216 mg/dl) and a glycosylated hemoglobin (HbA1C) of \>9% (75 mmol/mol) over the preceding 3 months
• •History of bleeding diathesis or cannot stop usage of an anti-coagulant until the International Normalized Ratio (INR) is below 1.5 or quick value \>70
• •Any genito-urinary malignancies which are not in remission for at least 2 years or considered cured, except prostate cancer
• •Previous AUS implant
• •Currently has another Active Implantable Medical Device (AIMD) implanted
• •Urge incontinence, mixed incontinence (MI) with a predominant urgency component
• •Overflow urinary incontinence
• •Neurogenic bladder dysfunction that is not treatable or controllable by pharmacological or any alternative methods
• •Abnormal or poor bladder compliance defined as being \<30 ml/ cm H2O
• •Bladder neck or urethral stricture that may require any long-term instrumental treatment