This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.
The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:
* pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites), * 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), * long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).
The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.
Male subject between 18 and 80 years (inclusive) of age at the time of consent signature
Subject with persistent urinary incontinence, defined as >12 months
Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 75 grams
Subject willing and able to provide written informed consent
Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
Subject with history of Artificial Urinary Sphincter or male sling implantation
Subject with history of pelvic radiotherapy
Subject with history of Artificial Urinary Sphincter-related urethral erosion
Single group
Artificial Urinary Sphincter implantation
DeviceDevice preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation) Implantation procedure which includes: * Perineal approach and bulbar urethral dissection * Inguinal approach * Cuff implantation around the urethra * Transmission cable passing * Surgery test procedure * Implantation of the Control Unit * Closure of the inguinal incision * Closure of the perineal incision * "Implant disabled mode" activation
Change in the 24-hour Pad Weight Test
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test at 3 months post-device activation compared to baseline.
Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period
All adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period, with their occurrence, severity and nature. All adverse events will be analysed and classified using the Clavien-Dindo classification grading system
Revision rate
Proportion of subjects who have been concerned with a revision between the implantation and each visit (or scheduled visit date), until the 10-year follow-up period
Explantation rate
Proportion of subjects who have been concerned with an explantation of the medical device between the implantation and each visit (or scheduled visit date), until the 10-year follow-up period
Renal function
Assessed using the serum creatinine
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