PRP Injections for Genitourinary Syndrome of Menopause

Vaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028009
• Other study ID #: STUDY00006805
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Medstar Health Research Institute
• Contact: Neha G Gaddam, M.D.
• Phone: 8328650244
• Email: neha.g.gaddam[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Postmenopausal Symptoms
• PRP
• Sexual Function Disturbances
• Syndrome
• Vaginal Atrophy

Intervention

Procedure:
• Injection of platelet-rich plasma
Injection of autologous platelet-rich plasma into anterior vaginal wall
• Injection of saline
Injection of sterile normal saline into anterior vaginal wall

Locations

Country	Name	City	State
United States	MedStar Lafayette Medical Centre	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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