PRP Injections for Genitourinary Syndrome of Menopause

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06028009
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PRP; Sexual Function Disturbances; Genitourinary Syndrome of Menopause; Postmenopausal Symptoms; Vaginal Atrophy	Procedure: Injection of platelet-rich plasma; Procedure: Injection of saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Platelet-rich plasma injection	Procedure: Injection of platelet-rich plasma; Injection of autologous platelet-rich plasma into anterior vaginal wall
Sham Comparator: 0.9% saline injection	Procedure: Injection of saline; Injection of sterile normal saline into anterior vaginal wall

Outcome Measures

Primary Outcome Measures

1. Female Sexual Function Index [Assessed at baseline and at 6 weeks and 6 months post-procedure]

   Validated questionnaire to assess domains of sexual function

Secondary Outcome Measures

1. Patient Global Impression of Improvement (PGI-I) [Assessed at 6 weeks and 6 months post-intervention]

   Single item questionnaire evaluating improvement in vaginal dryness

2. Visual analog scale for vaginal dryness (VAS) [Assessed at 6 weeks and 6 months post-intervention]

   Visual analog scale for vaginal dryness (VAS)

3. Urinary Distress Inventory (short form) (UDI-6) [Assessed at baseline and 6 weeks/6 months post-intervention]

   6 item questionnaire assessing urinary symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT06028009
• Other Study ID Numbers: STUDY00006805
• First Posted: Sep 7, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Syndrome

Study Results

No Results Posted as of Sep 7, 2023