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NCT Number: NCT05731284

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Procedure

Normal saline Injection

Primary outcomes

  1. Anterior wall descensus measured by the POP-Q System, Ba point

    Time frame: 12 month

    Anterior wall descensus measured by the POP-Q System, Ba point

Secondary outcomes

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

    Time frame: 12 months

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

  2. Posterior wall descensus

    Time frame: 12 months

    Posterior wall descensus measured by the POP-Q System, Bp point

  3. Leading edge

    Time frame: 12 months

    leading edge (Ba, C, or Bp) beyond the hymen (>0)

  4. Safety outcomes

    Time frame: 12 months

    operative time, blood loss, intra-, peri/postoperative adverse events

  5. Subjective

    Time frame: 12 months

    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)

  6. Retreatment

    Time frame: 12 months

    Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: PRP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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