PRP Injections for Genitourinary Syndrome of Menopause

MedStar Health

Status: Enrolling

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

Treatments: Procedure: Injection of platelet-rich plasma; Procedure: Injection of saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06028009

STUDY00006805

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Platelet-rich plasma injection

Experimental group

Treatment:

Procedure: Injection of platelet-rich plasma

0.9% saline injection

Sham Comparator group

Treatment:

Procedure: Injection of saline