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| ID | Type | Description | Link |
|---|---|---|---|
| 12-013 | Other Identifier | Research Ethics Board,JGH |
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| Name | Class |
|---|---|
| Université de Sherbrooke | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
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The study is designed to assess efficacy and subject satisfaction of two sling devices: Advance and Argus, in male patients with stress urinary incontinence after prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdVance | Active Comparator | sling procedure |
|
| ARGUS | Active Comparator | sling procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdVance® sling procedure | Procedure |
| ||
| ARGUS Sling procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) score and assess change in 24-hour pad weight . | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess change in subject satisfaction using questionnaires: ICIQ, UCLA-RAND Incontinence Index. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize all cumulative device and procedure related adverse events | 12 months |
Inclusion Criteria:
post-TURP, simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
A positive PT is confirmed with leakage of >8.O g/24h and < 400 g
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques Corcos, MD | Contact | 1-514-340-8222 | 5166 | jcorcos@jgh.mcgill.ca |
| Oleg Loutochin | Contact | 1-514-340-8222 | 1627 | oloutochin@jgh.mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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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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|
| 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 |