PRP Injections for Genitourinary Syndrome of Menopause

Not Applicable

Recruiting

• Conditions: Genitourinary Syndrome of Menopause; Postmenopausal Symptoms; Vaginal Atrophy; PRP; Sexual Function Disturbances
• Interventions: Procedure: Injection of platelet-rich plasma; Procedure: Injection of saline

• Registration Number: NCT06028009
• Lead Sponsor: Medstar Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-07
• Study Start: 2024-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Platelet-rich plasma injection	Injection of platelet-rich plasma	-
0.9% saline injection	Injection of saline	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MedStar Lafayette Medical Centre; 🇺🇸 Washington, District of Columbia, United States