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Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma injection | Experimental |
| |
| 0.9% saline injection | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of platelet-rich plasma | Procedure | Injection of autologous platelet-rich plasma into anterior vaginal wall |
|
| Measure | Description | Time Frame |
|---|---|---|
| Female Sexual Function Index | Validated questionnaire to assess domains of sexual function with range from 2 to 36 with lower score indicating worse sexual functioning (diagnostic for sexual dysfunction if score is less than or equal to 26.55) | Assessed at baseline and at 6 weeks and 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) | Single item questionnaire evaluating improvement in vaginal dryness with scale from 1 to 7 with lower score indicating greater improvement in vaginal dryness | Assessed at 6 weeks and 6 months post-intervention |
| Visual analog scale for vaginal dryness (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Lafayette Medical Centre | Washington D.C. | District of Columbia | 20036 | United States |
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| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Injection of saline | Procedure | Injection of sterile normal saline into anterior vaginal wall |
|
Visual analog scale for vaginal dryness (VAS) with range from 0 to 10 with higher score indicating higher degree of bothersome vaginal dryness |
| Assessed at 6 weeks and 6 months post-intervention |
| Urinary Distress Inventory (short form) (UDI-6) | 6 item questionnaire assessing urinary symptoms with range from 0-18 with higher score indicating greater distress related to urinary symptoms | Assessed at baseline and 6 weeks/6 months post-intervention |