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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Platelet rich plasma (PRP) Injection; Procedure: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adjunct Platelet rich plasma (PRP) therapy; 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; 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.
Placebo Comparator: Normal saline; 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; Normal saline Injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Isuzu Meyer, MD, MSPH, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: IRB-300009943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No