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PRP Injections for Genitourinary Syndrome of Menopause

Primary Purpose

PRP, Sexual Function Disturbances, Genitourinary Syndrome of Menopause

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injection of platelet-rich plasma
Injection of saline
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PRP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Platelet-rich plasma injection

    0.9% saline injection

    Arm Description

    Outcomes

    Primary Outcome Measures

    Female Sexual Function Index
    Validated questionnaire to assess domains of sexual function

    Secondary Outcome Measures

    Patient Global Impression of Improvement (PGI-I)
    Single item questionnaire evaluating improvement in vaginal dryness
    Visual analog scale for vaginal dryness (VAS)
    Visual analog scale for vaginal dryness (VAS)
    Urinary Distress Inventory (short form) (UDI-6)
    6 item questionnaire assessing urinary symptoms

    Full Information

    First Posted
    August 31, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Medstar Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06028009
    Brief Title
    PRP Injections for Genitourinary Syndrome of Menopause
    Official Title
    Vaginal Injection of Platelet Rich Plasma (PRP) for the Genitourinary Syndrome of Menopause (GSM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medstar Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PRP, Sexual Function Disturbances, Genitourinary Syndrome of Menopause, Postmenopausal Symptoms, Vaginal Atrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet-rich plasma injection
    Arm Type
    Experimental
    Arm Title
    0.9% saline injection
    Arm Type
    Sham Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Injection of platelet-rich plasma
    Intervention Description
    Injection of autologous platelet-rich plasma into anterior vaginal wall
    Intervention Type
    Procedure
    Intervention Name(s)
    Injection of saline
    Intervention Description
    Injection of sterile normal saline into anterior vaginal wall
    Primary Outcome Measure Information:
    Title
    Female Sexual Function Index
    Description
    Validated questionnaire to assess domains of sexual function
    Time Frame
    Assessed at baseline and at 6 weeks and 6 months post-procedure
    Secondary Outcome Measure Information:
    Title
    Patient Global Impression of Improvement (PGI-I)
    Description
    Single item questionnaire evaluating improvement in vaginal dryness
    Time Frame
    Assessed at 6 weeks and 6 months post-intervention
    Title
    Visual analog scale for vaginal dryness (VAS)
    Description
    Visual analog scale for vaginal dryness (VAS)
    Time Frame
    Assessed at 6 weeks and 6 months post-intervention
    Title
    Urinary Distress Inventory (short form) (UDI-6)
    Description
    6 item questionnaire assessing urinary symptoms
    Time Frame
    Assessed at baseline and 6 weeks/6 months post-intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Neha G Gaddam, M.D.
    Phone
    8328650244
    Email
    neha.g.gaddam@medstar.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Neha G Gaddam, M.D.
    Email
    gaddam.ng@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PRP Injections for Genitourinary Syndrome of Menopause

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