60 Participants Needed

PRP Therapy for Pelvic Organ Prolapse

(PRP Trial)

IM
SP
Overseen BySunita Patel
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Stay on Your Current MedsYou can continue your current medications while participating

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is PRP therapy safe for use in humans?

Platelet-rich plasma (PRP) therapy is generally considered safe for use in humans, as it is an autologous product (made from a person's own blood) that helps with tissue healing and regeneration. Studies have shown it to be a promising treatment with favorable safety outcomes for various conditions, including pelvic organ prolapse and other urogynaecological disorders.12345

How does PRP therapy differ from other treatments for pelvic organ prolapse?

PRP therapy is unique because it uses a patient's own blood to create a platelet-rich plasma that is rich in growth factors, which help in tissue healing and regeneration. Unlike synthetic meshes, PRP is a biological material that reduces the risk of foreign body reactions and complications, making it a potentially safer and more natural alternative for treating pelvic organ prolapse.12567

What data supports the effectiveness of PRP therapy for pelvic organ prolapse?

Research suggests that platelet-rich plasma (PRP) may help improve pelvic organ prolapse by increasing collagen concentration, which is important for tissue strength and healing. PRP has shown promise in treating other pelvic floor disorders, indicating it could be a useful alternative to more invasive treatments.12567

Who Is on the Research Team?

IM

Isuzu Meyer, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Completed child-bearing
I prefer surgery through a natural tissue method via the vagina.

Exclusion 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.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

PRP or normal saline is injected into the fibromuscular connective tissue during transvaginal native tissue prolapse surgery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including measures of descensus and adverse events

12 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Platelet rich plasma (PRP) Injection
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Adjunct Platelet rich plasma (PRP) therapyActive Control1 Intervention
Group II: Normal salinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Published Research Related to This Trial

In a study involving 10 postmenopausal women with pelvic organ prolapse (POP), it was found that coating vaginal implants with platelet-rich plasma (PRP) significantly improved the attachment of human vaginal fibroblasts (HVFs) to the implants, suggesting enhanced healing potential.
The results indicate that using PRP in urogynecologic surgeries could reduce complications related to mesh implants, as POP HVFs showed a much higher attachment rate to both absorbable and nonabsorbable meshes when treated with PRP compared to control media.
Attachment of Primary Vaginal Fibroblasts to Absorbable and Nonabsorbable Implant Materials Coated With Platelet-Rich Plasma: Potential Application in Pelvic Organ Prolapse Surgery.Medel, S., Alarab, M., Kufaishi, H., et al.[2015]
Platelet-rich plasma (PRP) shows promising potential as a treatment for stress urinary incontinence (SUI) and may enhance surgical outcomes for pelvic organ prolapse (POP), although current evidence is mainly from case series and animal studies.
PRP appears to have a favorable safety profile and beneficial effects in treating various pelvic floor disorders, including vaginal fistulas and genitourinary syndrome of menopause, but more rigorous studies are needed to confirm these findings.
Platelet rich plasma for the management of urogynecological disorders: the current evidence.Prodromidou, A., Grigoriadis, T., Athanasiou, S.[2023]
Platelet-rich plasma (PRP) shows promise as a treatment for pelvic floor disorders (PFDs), particularly for vaginal atrophy, where it improves symptoms and patient satisfaction, especially when hormone therapy is not an option.
PRP application has been associated with increased collagen concentration in pelvic organ prolapse (POP) and improvement in stress urinary incontinence symptoms, suggesting its potential effectiveness in managing various urogynaecological issues.
The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders.Prodromidou, A., Zacharakis, D., Athanasiou, S., et al.[2022]

Citations

Attachment of Primary Vaginal Fibroblasts to Absorbable and Nonabsorbable Implant Materials Coated With Platelet-Rich Plasma: Potential Application in Pelvic Organ Prolapse Surgery. [2015]
Platelet rich plasma for the management of urogynecological disorders: the current evidence. [2023]
The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders. [2022]
Platelet rich plasma as a minimally invasive approach to uterine prolapse. [2018]
Histological response to platelet-rich plasma added to polypropylene mesh implemented in rabbits. [2019]
Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]
Autologous platelet-rich plasma for treating chronic wounds. [2022]
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