Actively Recruiting
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
Led by Andalas University · Updated on 2025-09-08
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
Andalas University
Lead Sponsor
D
Dr. M Djamil Hospital, Padang
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of Platelet Rich Plasma (PRP) as an additional treatment during pelvic organ prolapse (POP) surgery. The study focuses on whether PRP affects the ratio of type I to III collagen and the levels of enzymes MMP-2 and MMP-9, which play roles in tissue repair. Researchers will compare patients undergoing prolapse surgery with PRP injection to those receiving surgery with a placebo injection. Participants will be randomly assigned to one of two groups: one receiving POP surgery combined with PRP injection, and the other receiving POP surgery with a placebo injection. PRP is prepared from the patient's own blood collected shortly before surgery and injected into the anterior vaginal wall. Biopsies from the vaginal mucosa will be taken before surgery and again eight weeks after to examine changes in collagen ratio and enzyme levels. Throughout the study, participants will undergo medical history review, physical exams, pelvic floor muscle strength tests, and pelvic organ prolapse quantification (POP-Q). Tissue samples from biopsies will be analyzed in a pathology lab to measure the primary outcomes of collagen ratio and enzyme levels. Secondary outcomes include pelvic floor muscle strength and recurrence of prolapse. The study involves follow-up assessments eight weeks after surgery to monitor these outcomes.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with second-degree or higher pelvic organ prolapse
- Postmenopausal pelvic organ prolapse patients
- Patients with pelvic organ prolapse who will undergo surgery
- Willingness to participate in the study
You will not qualify if you...
- Patients with gynecological malignancies
- Patients with a history of collagen disease
- Patients with blood disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 8 weeks
Participants undergo pelvic organ prolapse surgery with either PRP injection or placebo injection to study effects on collagen ratio and enzyme levels.
Hospitalization for surgery and 1 visit for injection on surgery day
Duration - 8 weeks
Participants are observed for 8 weeks after surgery, including punch biopsies to assess treatment effects.
1 follow-up visit approximately 8 weeks after surgery
Trial Site Locations
Total: 1 location
1
Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang
Padang, West Sumatera, Indonesia
Actively Recruiting
Research Team
Y
Yulia Margaretta Sari Yulia Margaretta, Sari, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here