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This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No perineorrhaphy | No Intervention | Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair | |
| Perineorrhaphy | Active Comparator | Subjects will have a perineorrhaphy added to the vaginal repair of prolapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineorrhaphy | Procedure | Procedure to build up the vaginal opening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sexual function as measured by validated questionnaire | Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery. | 6 months and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prolapse recurrence | A composite outcome score to define success of prolapse surgery will be applied to subjects at 6 and 12 months specifically looking for return of prolapse symptoms, anatomic recurrence, and need for retreatment | 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Candace Y Parker-Autry, MD | Wake Forest | Study Director |
| Holly E Richter, PhD, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Wake Forest University Health Sciences |
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| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |