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

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Platelet rich plasma (PRP) Injection; Procedure: Placebo

• Registration Number: NCT05731284
• Lead Sponsor: University of Alabama at Birmingham

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

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 Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Study Start: 2023-07-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-07-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjunct Platelet rich plasma (PRP) therapy	Platelet rich plasma (PRP) Injection	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.
Normal saline	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Anterior wall descensus measured by the POP-Q System, Ba point	12 month	Anterior wall descensus measured by the POP-Q System, Ba point

Secondary Outcome Measures

Name	Time	Method
Apical wall descensus measured by the POP-Q System, C point	12 months	Apical wall descensus measured by the POP-Q System, C point
Safety outcomes	12 months	operative time, blood loss, intra-, peri/postoperative adverse events
Retreatment	12 months	Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment)
Leading edge	12 months	leading edge (Ba, C, or Bp) beyond the hymen (\>0)
Posterior wall descensus	12 months	Posterior wall descensus measured by the POP-Q System, Bp point
Subjective	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)

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States