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The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MatriStem Pelvic Floor Matrix | Experimental | surgical mesh device |
|
| Native Tissue Repair | Active Comparator | suture repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MatriStem Pelvic Floor Matrix | Device |
| ||
| native tissue repair |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and effectiveness of surgical success/failure. | The composite outcome of surgical success evaluates anatomic outcome, patient reported outcome, and no retreatment pelvic organ prolapse. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The surgical success/failure based on an alternate definition of success. | A composite outcome of surgical success based on an alternate definition of anatomic success, patient reported outcome, and no retreatment for pelvic organ prolapse. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford School of Medicine | Stanford | California | 94305 | United States | ||
| Cleveland Clinic FLorida |
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| Procedure |
|
|
| Weston |
| Florida |
| 33331 |
| United States |
| Female Pelvic Medicine & Urogynecology | Grand Rapids | Michigan | 49503 | United States |
| Premier Urology Group | Edison | New Jersey | 08837 | United States |
| Atlantic Health System | Morristown | New Jersey | 07960 | United States |
| Princeton Urogynecology | Princeton | New Jersey | 08540 | United States |
| Garden State Urology | Whippany | New Jersey | 07981 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18103 | United States |
| Center for Pelvic Health | Franklin | Tennessee | 37067 | United States |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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