Pelvic Organ Prolapse
Conditions
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.
Interventions
PROCEDUREPlatelet rich plasma (PRP) Injection
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.
PROCEDUREPlacebo
Normal saline Injection
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior wall descensus measured by the POP-Q System, Ba point | 12 month | Anterior wall descensus measured by the POP-Q System, Ba point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apical wall descensus measured by the POP-Q System, C point | 12 months | Apical wall descensus measured by the POP-Q System, C point |
| Posterior wall descensus | 12 months | Posterior wall descensus measured by the POP-Q System, Bp point |
| Leading edge | 12 months | leading edge (Ba, C, or Bp) beyond the hymen (\>0) |
| Safety outcomes | 12 months | operative time, blood loss, intra-, peri/postoperative adverse events |
| Subjective | 12 months | 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) |
| Retreatment | 12 months | Retreatment for prolapse: pessary or surgery - dichotomous (failure: retreatment) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIsuzu Meyer, MD, MSPH
The University of Alabama at Birmingham
Outcome results
None listed