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

NCT05731284 | Active Not Recruiting

• 1 other identifier: IRB-300009943
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Apical wall descensus measured by the POP-Q System, C point

  12 months

• Posterior wall descensus

  12 months

• Leading edge

  12 months

• Safety outcomes

  12 months

• Subjective

  12 months

Study Arms (2)

Adjunct Platelet rich plasma (PRP) therapy

ACTIVE COMPARATOR

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

Normal saline

PLACEBO COMPARATOR

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

Interventions

Platelet rich plasma (PRP) Injection PROCEDURE

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.

Adjunct Platelet rich plasma (PRP) therapy

Placebo PROCEDURE

Normal saline Injection

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Desire surgical treatment via a transvaginal native tissue approach.
• Completed child-bearing

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Injections

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Isuzu Meyer, MD, MSPH

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking: Participants and study examiners performing the postoperative assessment will remain masked to the intervention assignment for the study duration, unless a medical indication for unmasking is identified.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 16, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)