Using platelet-rich plasma to improve surgery outcomes for pelvic organ prolapse
Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
This study tests if injecting a treatment made from a patient's own blood into vaginal tissue during pelvic organ prolapse surgery can help women heal better and reduce the chances of the problem coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05731284 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of injecting platelet-rich plasma (PRP) into vaginal tissue during prolapse surgery to enhance healing and surgical outcomes. PRP, derived from the patient's own blood, contains growth factors that may promote tissue regeneration and reduce recurrence rates. The focus is on its application at the site of highest recurrence risk during anterior colporrhaphy in women undergoing native tissue vaginal prolapse repair. The study aims to determine both the safety and efficacy of this adjunct therapy compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are women who have completed child-bearing and desire surgical treatment for pelvic organ prolapse via a transvaginal approach.
Not a fit: Patients who have had prior pelvic surgery within the last 12 months or those with a history of solid organ malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced recurrence rates for women undergoing prolapse surgery.
How similar studies have performed: While the use of PRP in surgical settings is gaining interest, this specific application in pelvic organ prolapse surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Isuzu Meyer, MD, MSPH — The University of Alabama at Birmingham
- Study coordinator: Isuzu Meyer, MD. MSPH
- Email: imeyer@uabmc.edu
- Phone: (205) 996-9580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.