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

N/AActive Not RecruitingNCT05731284

University of Alabama at Birmingham60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Platelet rich plasma (PRP) InjectionPROCEDURE

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.

PlaceboPROCEDURE

Normal saline Injection

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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

Time frame: 12 month

Secondary Outcomes

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

Time frame: 12 months

Posterior wall descensus

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

Time frame: 12 months

Leading edge

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

Time frame: 12 months

Safety outcomes

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

Time frame: 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)

Time frame: 12 months

Retreatment

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

Time frame: 12 months

Data from ClinicalTrials.gov

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