Platelet-rich plasma to improve healing after pelvic organ prolapse repair
The Effects of Platelet Rich Plasma Adjuvant to Type I/III Collagen Ratio, Matrix Metalloproteinase-2 and Matrix Metalloproteinase-9 in Pelvic Organ Prolapse Repair
This trial will try giving platelet-rich plasma during pelvic organ prolapse repair to see if it changes collagen balance and levels of MMP-2 and MMP-9 that affect healing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Andalas University Academic / other |
| Locations | 1 site (Padang, West Sumatera) |
| Trial ID | NCT07150442 on ClinicalTrials.gov |
What this trial studies
This is a randomized, participant-blinded interventional trial comparing pelvic organ prolapse surgery with autologous platelet-rich plasma (PRP) injection versus surgery with placebo injection. PRP is prepared from each patient's own blood on the day of surgery and injected into the anterior vaginal mucosa at the pubocervical fascia during reconstructive surgery. Punch biopsies of the anterior vaginal mucosa are taken at surgery and again about eight weeks postoperatively, and tissues undergo immunohistochemistry to compare type I/III collagen ratio and MMP-2 and MMP-9 expression. The study is conducted at Andalas University in collaboration with Dr. M. Djamil Hospital in Padang, West Sumatra.
Who should consider this trial
Good fit: Postmenopausal women with stage II or higher pelvic organ prolapse who are scheduled for surgical repair and willing to undergo biopsies and follow-up are ideal candidates.
Not a fit: Patients with gynecologic malignancy, known collagen disorders, blood disorders, or those not undergoing surgery or unwilling to have biopsies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding PRP could improve tissue healing after prolapse repair and potentially reduce recurrence by favorably altering collagen composition and MMP activity.
How similar studies have performed: PRP has been used in other surgical and gynecologic settings with mixed results and limited high-quality data, so its application in prolapse repair remains relatively experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with second-degree or higher pelvic organ prolapse 2. Postmenopausal pelvic organ prolapse patients 3. Patients with pelvic organ prolapse who will undergo surgery 4. Willingness to participate in the study Exclusion Criteria: 1. Patients with gynecological malignancies 2. Patients with a history of collagen disease 3. Patients with blood disorders
Where this trial is running
Padang, West Sumatera
- Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang — Padang, West Sumatera, Indonesia (Recruiting)
Study contacts
- Principal investigator: Yulia Margaretta Sari Yulia Margaretta, Sari, MD, MD — Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang Indonesia
- Study coordinator: Yulia Margaretta Sari Yulia Margaretta, Sari, MD
- Email: yulia_kino@yahoo.com
- Phone: +6281363462158
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.