ARTUS MONO Artificial Urinary Sphincter

Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.

Inclusion Criteria:

1. Female patients aged ≥ 18 yo
2. BMI > 18,5 and < 35
3. Patient scheduled for an anterior pelvic exenteration with ileal conduit urinary diversion
4. Signed informed consent

Exclusion Criteria:

1. Advanced bladder cancer with bladder neck and/or urethral extension
2. Past pelvic radiation therapy
3. Patient previously treated with an artificial urinary sphincter or other urogenital implant
4. Positive urine culture during the past 2 weeks
5. Indwelling bladder catheter during the past 2 weeks
6. Documented history of sensitivity to silicone
7. History of connectivitis disease
8. Immunosuppressive therapy in the last 3 months
9. Vulnerable subjects
10. Participation in any other clinical investigation