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PRP Injections for Postmenopausal Syndrome

N/A
Recruiting
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women (assigned female at birth) at least 18 years old with a clinical diagnosis of GSM
Be older than 18 years old
Must not have
Symptomatic pelvic organ prolapse protruding beyond the hymen
History of pelvic radiation or genital tract malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 6 weeks and 6 months post-intervention

Summary

This trial is testing whether injections of platelet-rich plasma (PRP) into the anterior vaginal wall can improve sexual functioning in women experiencing symptoms of menopause. PRP is a solution with a high

Who is the study for?
This trial is for English-speaking women, assigned female at birth, who are at least 18 years old and have been diagnosed with genitourinary syndrome of menopause (GSM). Participants should be sexually active, having had sexual activity weekly in the past month. They must also be willing to follow study requirements.
What is being tested?
The trial is testing if injections of platelet-rich plasma (PRP) into the vaginal wall can improve sexual function in women with GSM. PRP is a concentration of platelets from your own blood that may stimulate cell growth. The study compares PRP injections against saline (saltwater) injections.
What are the potential side effects?
While PRP uses the patient's own blood and is generally considered safe with minimal side effects, potential risks could include pain at injection site, infection, or tissue damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman over 18 with a diagnosis of GSM.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a pelvic organ prolapse that is visible outside my vaginal opening.
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I have had radiation treatment in my pelvic area or cancer in my genital tract.
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I cannot take blood thinners.
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I have a skin condition or infection in my genital area.
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I am not pregnant and have gone through menopause.
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I have noticeable pelvic organ prolapse symptoms.
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I have had surgery involving vaginal or midurethral mesh.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 6 weeks and 6 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 6 weeks and 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Female Sexual Function Index
Secondary study objectives
Patient Global Impression of Improvement (PGI-I)
Urinary Distress Inventory (short form) (UDI-6)
Visual analog scale for vaginal dryness (VAS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet-rich plasma injectionExperimental Treatment1 Intervention
Group II: 0.9% saline injectionPlacebo Group1 Intervention

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Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
195 Previous Clinical Trials
183,129 Total Patients Enrolled
~0 spots leftby Dec 2024
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