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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Platelet rich plasma (PRP) Injection; Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05731284

IRB-300009943

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Adjunct Platelet rich plasma (PRP) therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Platelet rich plasma (PRP) Injection

Normal saline

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Placebo