Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Anterior wall descensus measured by the POP-Q System, Ba point
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Adjunct Platelet rich plasma (PRP) therapy
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.
Intervention: Platelet rich plasma (PRP) Injection (Procedure)
Normal saline
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.
Intervention: Placebo (Procedure)
Outcomes
Primary Outcomes
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
- Apical wall descensus measured by the POP-Q System, C point(12 months)
- Safety outcomes(12 months)
- Retreatment(12 months)
- Leading edge(12 months)
- Posterior wall descensus(12 months)
- Subjective(12 months)
Investigators
Isuzu Meyer
Associate Professor
University of Alabama at Birmingham