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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether injecting platelet-rich plasma (PRP) can improve surgical outcomes for pelvic organ prolapse, a condition where pelvic organs drop from their normal position. PRP, a substance made from the patient's own blood, may aid healing and is being tested alongside standard surgery. Participants will receive either PRP injections or a placebo (a harmless substance) during their surgery to determine which is more effective. This trial suits individuals seeking surgery for pelvic organ prolapse who have completed childbearing.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that platelet-rich plasma (PRP) therapy is safe for pelvic organ prolapse surgery?

Research has shown that platelet-rich plasma (PRP) injections are generally safe. In one study, 600 women with pelvic floor problems received PRP treatment. The results indicated that PRP improved their conditions and was well-accepted by the patients. Another smaller study found that local PRP injections were safe and effective for treating issues like stress urinary incontinence. These studies suggest that PRP injections do not cause major side effects, making them a promising option for surgeries such as those for pelvic organ prolapse. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PRP therapy for pelvic organ prolapse because it offers a novel approach compared to traditional surgical repairs or pessaries. Unlike other treatments that focus on mechanical support or surgical correction, PRP therapy uses the body's own platelet-rich plasma to potentially enhance tissue repair and regeneration in the pelvic area. This method targets the underlying structural issues by promoting natural healing and strengthening of the connective tissues, which could lead to more sustainable results and fewer complications over time.

What evidence suggests that PRP therapy might be an effective treatment for pelvic organ prolapse?

This trial will compare the effectiveness of Platelet-rich plasma (PRP) therapy with a placebo treatment for pelvic organ prolapse. Research has shown that PRP therapy offers potential benefits for related health issues. In studies on PRP for stress urinary incontinence, where urine leaks during activities like sneezing or coughing, 80.8% of patients experienced positive results. Another study found that PRP might help treat cystocele, a type of pelvic organ prolapse, and could prevent its recurrence. While these studies focused on similar conditions, the positive outcomes suggest PRP might also be effective for pelvic organ prolapse. More research is needed to confirm these findings, but early results are promising. ^{1 3 5 6 7}

Who Is on the Research Team?

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.

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?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12194431/

PRP Therapy for Stress Urinary Incontinence and Pelvic ... Following the PRP treatment, 80.8% of patients reported a positive response in alleviating SUI, with 50% achieving a GRA ≥ 2, which was ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/nau.25365

Autologous platelet rich plasma (A‐PRP) combined with ... Positive outcomes have been reported when A-PRP is used to treat SUI in women by injection at the anterior vaginal mucosa below the urethral ...

3. nature.com nature.com/articles/s41598-020-80598-2

A pilot study: effectiveness of local injection of autologous ... Local injection of autologous platelet rich plasma seems safe with somewhat satisfactory response in treating female SUI both at 1 month and 6 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38108468/

Autologous platelet rich plasma (A-PRP) combined with ... A-PRP + PFMT could be a treatment option for women with SUI. Large Phase III randomized controlled trials are required to confirm our findings.

5. f1000research.com f1000research.com/articles/13-1508

Platelet-rich plasma as a potential therapy of cystocele PRP has the potential to be a good alternative treatment to prevent cystocele recurrence. However, it cannot be generalized to large populations ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869963/

Role of platelet-rich plasma in pelvic floor disorders A total of 600 women with various pelvic floor disorders treated with PRP were analyzed. PRP positively impacts female sexual dysfunction, perineal trauma, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05731284

Platelet Rich Plasma as an Adjunct Therapy at the Time of ... This is a double-blind study. During vaginal prolapse surgery, the surgeon will inject PRP into the vaginal tissue at the surgical site. Participant Group/Arm ...