Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
Purpose
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
Condition
- Pelvic Organ Prolapse
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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. |
|
|
Placebo Comparator 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. |
|
Recruiting Locations
Birmingham, Alabama 35249
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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.