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

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

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

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.

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.

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.

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.

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.

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)

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