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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
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anterior wall descensus measured by the POP-Q System, Ba point
Secondary study objectives
Apical wall descensus measured by the POP-Q System, C point
Leading edge
Posterior wall descensus
+3 moreTrial 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
1,656 Previous Clinical Trials
2,444,315 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received radiation therapy in my abdomen or pelvis.I have had surgery in my pelvic area within the last year.I am able to follow and participate in the study as required.I have a lump in my pelvic area.I have had surgery to lift the front or top of my pelvic organs.I have had surgery to fix prolapse with graft augmentation.I have had cancer in a solid organ before.I prefer surgery through a natural tissue method via the vagina.
Research Study Groups:
This trial has the following groups:- Group 1: Adjunct Platelet rich plasma (PRP) therapy
- Group 2: Normal saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.