PRP Therapy for Pelvic Organ Prolapse

(PRP Trial)

Overseen By Sunita Patel

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pelvic radiation, Pelvic mass, Malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 3 4 5}

Research Team

Isuzu Meyer, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Adjunct Platelet rich plasma (PRP) therapy Active Control 1 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 saline Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Pelvic organ prolapse (POP) significantly affects women's health and quality of life, and while synthetic meshes have been associated with severe complications, there is a growing interest in using biological grafts, though their routine use lacks conclusive evidence.

Platelet-rich plasma (PRP) shows promise as a potential treatment for POP due to its rich content of growth factors and cytokines, which could aid in tissue reconstruction, and it is safer than synthetic materials, warranting further research in clinical and animal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet rich plasma as a minimally invasive approach to uterine prolapse. Chrysanthopoulou, EL., Pergialiotis, V., Perrea, D., et al.[2018]

In a study involving 30 female rabbits, the use of platelet-rich plasma (PRP) with polypropylene meshes (PPM) significantly reduced inflammatory cell presence at 90 days post-implantation, indicating a potential for improved healing.

PRP application led to increased production of collagen types I and III within seven days of implantation, suggesting that PRP enhances tissue repair processes associated with PPM use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histological response to platelet-rich plasma added to polypropylene mesh implemented in rabbits. Ávila, OR., Parizzi, NG., Souza, AP., et al.[2019]

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

A systematic review of nine randomized controlled trials involving 325 participants found no significant difference in the healing of chronic wounds when comparing autologous platelet-rich plasma (PRP) to standard treatments or placebo.

While some results showed a higher percentage of wound area healed with PRP in mixed chronic wounds, overall evidence does not support the efficacy of PRP for chronic wound treatment, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Attachment of Primary Vaginal Fibroblasts to Absorbable and Nonabsorbable Implant Materials Coated With Platelet-Rich Plasma: Potential Application in Pelvic Organ Prolapse Surgery. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Platelet rich plasma for the management of urogynecological disorders: the current evidence. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Emerging Role on the Use of Platelet-Rich Plasma Products in the Management of Urogynaecological Disorders. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Platelet rich plasma as a minimally invasive approach to uterine prolapse. [2018]

5. Brazil pubmed.ncbi.nlm.nih.gov

Histological response to platelet-rich plasma added to polypropylene mesh implemented in rabbits. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]