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

Study Overview
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Brief Summary
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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

Detailed Description
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Platelet rich plasma (PRP) is an autologous product with high levels of platelets which are concentrated with bioactive growth factors responsible for accelerating tissue healing by stimulating the number of reparative cells to create collagen production, angiogenesis and neurogenesis. The overarching goal is to evaluate the effectiveness and safety of the adjunct application of PRP in the fibromuscular connective tissue (the site of anterior tissue plication) at the time of anterior colporrhaphy (the site of highest recurrence risk) in women undergoing native tissue vaginal prolapse repair, to promote tissue healing and regeneration, thus to improve surgical outcomes.

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Platelet rich plasma (PRP) Injection
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Desire surgical treatment via a transvaginal native tissue approach. Completed child-bearing Exclusion Criteria: Unable to follow-up, not willing to, or unable to participate in the proposed study Prior pelvic surgery within the past 12 months Prior anterior/apical suspension procedures Prior graft augmented prolapse surgery Pelvic/abdominal radiation Pelvic mass History of solid organ malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adjunct Platelet rich plasma (PRP) therapy<br>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. | Procedure: Platelet rich plasma (PRP) Injection<br>* Randomly picked (like the flip of a coin) by a computer to receive either platelet-rich plasma (PRP) or normal saline. This is a double-blind study. During vaginal prolapse surgery, the surgeon will inject PRP into the vaginal tissue at the surgical site.<br>|
| Placebo Comparator: Normal saline<br>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. | Procedure: Placebo<br>* Normal saline Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior wall descensus measured by the POP-Q System, Ba point | Anterior wall descensus measured by the POP-Q System, Ba point | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apical wall descensus measured by the POP-Q System, C point | Apical wall descensus measured by the POP-Q System, C point | 12 months | 
| Posterior wall descensus | Posterior wall descensus measured by the POP-Q System, Bp point | 12 months | 
| Leading edge | leading edge (Ba, C, or Bp) beyond the hymen (>0) | 12 months | 
| Safety outcomes | operative time, blood loss, intra-, peri/postoperative adverse events | 12 months | 
| Subjective | Bothersome vaginal bulge symptoms (positive response to usually have a bulge or something falling out that you can see or feel in your vaginal area from the PFDI-20) | 12 months | 
| Retreatment | Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment) | 12 months |