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.
Female subject over 18 years of age at the time of consent signature
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 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
Single group
Artificial Urinary Sphincter ARTUS
DeviceThe 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.
Adverse Device Effect Incidence
all adverse device effects (device and/or procedure related) occurring from the implantation up to the 3 months post-operative visit, with their occurrence, severity, and nature. These events will be analyzed and classified using the Clavien-Dindo classification grading system.
Adverse Events Incidence
all adverse events (including adverse device effect) occurring peri-operatively, 30 days after implantation and at 3, 6, 12 and 24-months post-operative with their occurrence, severity, and nature. All adverse events will be analyzed and classified using the Clavien-Dindo classification grading system
Revision Rate
Proportion of subjects with a revision of the Artificial Urinary Sphincter
Explantation Rate
Proportion of subjects with a definitive explantation of the Artificial Urinary Sphincter
Evolution of Renal Function
Measure of the serum creatinine
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