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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,602 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you inform me if enrollment for this experiment is presently being sought?

"As per the clinicaltrials.gov website, this trial was initially published on March 1st 2023 and has since been updated most recently on February 7th 2023. Unfortunately, patient recruitment for this study is no longer taking place; however there are 83 other trials actively recruiting now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery

Isuzu Meyer 2023. "Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05731284.