Genitourinary Syndrome of Menopause, Postmenopausal Symptoms, PRP, Sexual Function Disturbances, Vaginal Atrophy
Conditions
Brief summary
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.
Interventions
PROCEDUREInjection of platelet-rich plasma
Injection of autologous platelet-rich plasma into anterior vaginal wall
PROCEDUREInjection of saline
Injection of sterile normal saline into anterior vaginal wall
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM * Sexually active with at least one episode of sexual activity per week in the preceding 4 weeks defined as follows: Partnered or solo penetrative or non-penetrative stimulation of the clitoris or vagina * English-speaking * Willingness and able to comply with the study requirements
Exclusion criteria
* Symptomatic pelvic organ prolapse protruding beyond the hymen) * History of prior vaginal mesh or midurethral mesh sling surgery * History of pelvic radiation or genital tract malignancy * Current symptomatic pelvic organ prolapse (stage II or greater) * Active vulvar dermatoses or genitourinary infection * Unable to hold anticoagulation * Hormonal replacement therapy (systemic, local, or vaginal) within 3 months of participation * Pregnancy or pre-menopausal status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index | Assessed at baseline and at 6 weeks and 6 months post-procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) | Assessed at 6 weeks and 6 months post-intervention | Single item questionnaire evaluating improvement in vaginal dryness with scale from 1 to 7 with lower score indicating greater improvement in vaginal dryness |
| Visual analog scale for vaginal dryness (VAS) | Assessed at 6 weeks and 6 months post-intervention | Visual analog scale for vaginal dryness (VAS) with range from 0 to 10 with higher score indicating higher degree of bothersome vaginal dryness |
| Urinary Distress Inventory (short form) (UDI-6) | Assessed at baseline and 6 weeks/6 months post-intervention | 6 item questionnaire assessing urinary symptoms with range from 0-18 with higher score indicating greater distress related to urinary symptoms |
Countries
United States
Outcome results
None listed