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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This is a multi-centre randomized controlled trial comparing mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) and autologous fascia sling (AFS) in elderly patients with stress predominant urinary incontinence. The investigators aim to investigate new onset pelvic pain 6 months post-op and objective urinary incontinence cure rate 5 years post-op. Secondary objectives include investigation of opioid use, mental health, sexual health, and other post-op outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tension-free vaginal tape | Active Comparator |
| |
| autologous fascia sling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous fascia sling | Procedure | Participants will receive autologous fascia sling as surgery for stress predominant urinary incontinence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective urinary incontinence status measured by standing cough test | Unit of measure: proportion of participants Measurement tool: standing cough test positive, yes/no | 5 years post-op |
| Incidence of new-onset chronic abdominopelvic pain since surgery by Likert pain intensity scale | Proportion of participants who report new abdominopelvic pain with an average intensity greater than 3 on a 0-10 Likert pain intensity scale over the past 6 months | 6 months post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| tension-free vaginal tape | Procedure | Participants will receive tension-free vaginal tape as surgery for stress predominant urinary incontinence. |
|
| 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 |