PRP Injections for Genitourinary Syndrome of Menopause

Study Overview
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Brief Summary
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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.

Official Title
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Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)

Conditions
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PRP, Sexual Function Disturbances, Genitourinary Syndrome of Menopause, Postmenopausal Symptoms, Vaginal Atrophy

Intervention / Treatment
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* Procedure: Injection of platelet-rich plasma
* Procedure: Injection of saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet-rich plasma injection<br> | Procedure: Injection of platelet-rich plasma<br>* Injection of autologous platelet-rich plasma into anterior vaginal wall<br>|
| Sham Comparator: 0.9% saline injection<br> | Procedure: Injection of saline<br>* Injection of sterile normal saline into anterior vaginal wall<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |