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| Name | Class |
|---|---|
| Good Samaritan Hospital, Ohio | OTHER |
| Greater Baltimore Medical Center | OTHER |
| American Medical Systems | INDUSTRY |
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Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tension-free Vaginal Tape | Active Comparator |
| |
| Monarc Sub-fascial hammock | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tension-free Vaginal Tape | Device |
| ||
| Monarc sub-fascial hammock |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of abnormal bladder function, defined as the sign or symptom of urinary incontinence or urinary retention | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | ||
| Postoperative pain | 2 weeks, 6 weeks | |
| HRQOL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew D Barber, MD, MHS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States | ||
| Good Samaritan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18310363 | Derived | Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e. |
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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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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Device |
|
| 6 months, 12 months, 18 months, 24 months |
| Sexual function | 12 months, 24 months |
| Global improvement in bladder function | 6 months, 12 months, 18 months, 24 months |
| Development of anterior vaginal prolapse | 12 months, 24 months |
| Cincinnati |
| Ohio |
| 45520 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| 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 |