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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

MedStar Lafayette Medical Centre
Washington, District of Columbia 20036
Contact:
Neha G Gaddam
832-865-0244
gaddam.ng@gmail.com

More Details

Status
Recruiting
Sponsor
Medstar Health Research Institute

Study Contact

Neha G Gaddam, M.D.
8328650244
neha.g.gaddam@medstar.net

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.