Active — Not RecruitingNot Applicable

PRP Injections for Genitourinary Syndrome of Menopause

United States30 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Female Sexual Function Index

Timeframe: Assessed at baseline and at 6 weeks and 6 months post-procedure

Trial details

NCT IDNCT06028009

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31