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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Injection of autologous platelet-rich plasma into anterior vaginal wall
Injection of sterile normal saline into anterior vaginal wall
MedStar Lafayette Medical Centre
Washington D.C., District of Columbia, United States
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)
Time frame: Assessed at baseline and at 6 weeks and 6 months post-procedure
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
Time frame: Assessed at 6 weeks and 6 months post-intervention
Visual analog scale for vaginal dryness (VAS)
Visual analog scale for vaginal dryness (VAS) with range from 0 to 10 with higher score indicating higher degree of bothersome vaginal dryness
Time frame: 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
Time frame: Assessed at baseline and 6 weeks/6 months post-intervention
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