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PRP Therapy for Pelvic Organ Prolapse (PRP Trial)

N/A
Recruiting
Led By Isuzu Meyer, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

PRP Trial Summary

This trial looks at whether adding PRP to prolapse surgery could improve outcomes, such as pain and sexual function.

Who is the study for?
This trial is for individuals seeking surgical treatment for pelvic organ prolapse via a transvaginal approach and have finished having children. It's not suitable for those who can't follow up, had recent pelvic surgery, received radiation in the pelvis/abdomen, have a pelvic mass or history of certain surgeries and solid organ cancer.Check my eligibility
What is being tested?
The study tests if injecting platelet-rich plasma (PRP) into vaginal tissue during prolapse surgery improves outcomes. Participants will either receive PRP injections or a placebo without knowing which one they get.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, infection risk, bleeding or bruising. Since PRP uses the patient's own blood components, allergic reactions are less likely.

PRP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anterior wall descensus measured by the POP-Q System, Ba point
Secondary outcome measures
Apical wall descensus measured by the POP-Q System, C point
Leading edge
Posterior wall descensus
+3 more

PRP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Adjunct Platelet rich plasma (PRP) therapyActive Control1 Intervention
Study Interventions: PRP will be injected in a systematic grid like fashion into the fibromuscular connective tissue of the anterior compartment following vaginal incision and dissection.
Group II: Normal salinePlacebo Group1 Intervention
Placebo: Normal saline will be injected in a systematic grid like fashion into the fibromuscular connective tissue of the anterior compartment following vaginal incision and dissection.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,598 Previous Clinical Trials
2,286,692 Total Patients Enrolled
4 Trials studying Pelvic Organ Prolapse
516 Patients Enrolled for Pelvic Organ Prolapse
Isuzu Meyer, MD, MSPHPrincipal InvestigatorThe University of Alabama at Birmingham

Media Library

Adjunct Platelet rich plasma (PRP) therapy Clinical Trial Eligibility Overview. Trial Name: NCT05731284 — N/A
Pelvic Organ Prolapse Research Study Groups: Adjunct Platelet rich plasma (PRP) therapy, Normal saline
Pelvic Organ Prolapse Clinical Trial 2023: Adjunct Platelet rich plasma (PRP) therapy Highlights & Side Effects. Trial Name: NCT05731284 — N/A
Adjunct Platelet rich plasma (PRP) therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05731284 — N/A
~40 spots leftby Jul 2026