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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | ARTUS MONO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTUS MONO | Device | Temporarily implant and activation of the medical device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bladder catheterization in presence of ARTUS MONO cuff | Injection then re-aspiration of 50 cc of saline water through 18 Fr Foley catheter | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| ARTUS MONO cuff implant | Visual analogic scale (from worst to best imaginable easiness and safety) | Day 0 |
| ARTUS MONO cuff activation | Cuff closing to reach 10, 20 and 30% of urethral perimeter reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas BARRY DELONGCHAMPS, PR | Hôpital Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomayer hospital | Prague | Czechia | ||||
| Cochin Hospital |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Day 0 |
| Paris |
| 75014 |
| France |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |