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| Name | Class |
|---|---|
| American College of Obstetricians and Gynecologists | OTHER |
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This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No dilator use | No Intervention | ||
| Dilator use | Active Comparator | Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilator use | Behavioral | Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12 | 6 month |
| Physical exam | Change in vaginal caliber and POP Q measurements 3 and 6 months after vaginal reconstructive surgery and its relation to sexual function scores and rates of dyspareunia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23812462 | Derived | Antosh DD, Gutman RE, Park AJ, Sokol AI, Peterson JL, Kingsberg SA, Iglesia CB. Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jun;121(6):1273-1280. doi: 10.1097/AOG.0b013e3182932ce2. |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| D004414 | Dyspareunia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| 6 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |