PRP Injections for Genitourinary Syndrome of Menopause

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Atrophy; Postmenopausal Symptoms; Genitourinary Syndrome of Menopause; Sexual Function Disturbances; PRP
• Intervention / Treatment: Procedure: Injection of platelet-rich plasma; Procedure: Injection of saline

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neha G Gaddam, M.D.; Phone Number: 8328650244; Email: neha.g.gaddam@medstar.net
• Study Contact Backup: Name: Neha G Gaddam, M.D.; Email: gaddam.ng@gmail.com

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Recruiting
      • MedStar Lafayette Medical Centre
      • Contact: Neha G Gaddam; Phone Number: 832-865-0244; Email: gaddam.ng@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: STUDY00006805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No