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 (POP PRP MMP)

The goal of this clinical trial is to analyze the effect of Platelet Rich Plasma (PRP) Adjuvant To Type I/III Colagen Ratio, MMP-2 and MMP-9 in Pelvic Organ Prolapse Repair.

The main questions it aims to answer are:

Does the PRP Adjuvant affect type I/III Colagen Ratio, MMP-2 and MMP-9 in Pelvic Organ Prolapse Repair? Researchers will compare patient who undergo prolapse surgery with PRP adjuvant versus patient who undergo prolapse surgery without PRP adjuvant (placeebo)

Participants will:

Patient will undergo pelvic organ prolapse reconstrucion surgery and punch biopsy and injection of PRP will perform in anterior vaginal mucosa at Pubocervical area. The second biopsy will attempt in 8 weeks post operative. imunohistochemistry examination will be done to compare the type I/III Colagen Ratio, MMP-2 and MMP-9 before and after surgery.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse Vaginal Surgery; Platelet Rich Plasma Injection
• Intervention / Treatment: Procedure: POP surgery and PRP injection; Procedure: POP surgery and placebo injection

Detailed Description

1. Prepare tools and materials for the research.
2. Align perceptions with the research team to conduct well-guided interviews.
3. Patients who meet the inclusion and exclusion criteria will be given an explanation and a research information sheet and asked for consent to participate in the study.
4. Subjects who agree to participate in the study will then undergo a urogynecological medical record and gynecological physical examination, pelvic floor muscle strength, and POP Q.
5. Randomization of study subjects will be performed.
6. Participants are unaware of whether they would receive PRP therapy or a placebo.
7. The study subjects were hospitalized in preparation for surgery, in accordance with the regulations of the hospital where the study subjects were located.
8. PRP was prepared from the patient's own blood on the day of surgery. Blood was drawn no later than one hour before surgery. Twenty milliliters of blood was collected for processing into PRP.
9. Participant undergo pelvic organ prolapse surgery as a medically indicated treatment for pelvic organ prolapse.
10. Punch biopsies were performed on the anterior vaginal mucosa located in the Fascia Pubocervicalis area, 6 mm deep. The tissue was sent in a special medium to the Anatomical Pathology Laboratory of Dr. M. Djamil General Hospital.
11. PRP or placebo injections were administered based on a random number sequence determined by block randomization among subjects undergoing POP surgery in the Surgical Unit of the hospital where the study subjects were located.
12. The PRP preparation was placed in a 5 cc syringe.
13. The placebo preparation, containing NaCl solution, was placed in a 5 cc syringe.
14. The injection was performed by the POP surgery operator into the anterior vaginal wall to a depth of approximately 1-1.5 cm, estimating the location of the Fascia Pubocervicalis.
15. Further observation was conducted 8 weeks after surgery, involving punch biopsies of the anterior vaginal mucosa from three sites. These were then sent on special media to the Anatomical Pathology Laboratory of Dr. M. Djamil General Hospital for examination of the type I/III collagen ratio, MMP-2, and MMP-9.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yulia Margaretta Sari Yulia Margaretta, Sari, MD; Phone Number: +6281363462158; Email: yulia_kino@yahoo.com

Study Locations

• Indonesia
  • West Sumatera
    • Padang, West Sumatera, Indonesia
      • Recruiting
      • Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang
      • Contact: Yulia Margaretta Sari, MD; Phone Number: +6281363462158; Email: yulia_kino@yahoo.com
      • Principal Investigator: Yulia Margaretta Sari, MD
      • Sub-Investigator: Aisyah Elliyanti, Prof, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; patient who receive POP surgery and PRP injection	Procedure: POP surgery and PRP injection; Patient who undergo POP surgery will receive PRP injection
Experimental: Group B; patient who receive POP surgery and placebo injection	Procedure: POP surgery and placebo injection; patient who receive POP surgery and placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type I/III collagen ratio	The evaluation of Type I/III collagen ratio are based on imunohistochemistry from punch biopsy in anterior vaginal mucosa that taken durung surgery and at 8 weeks post operative	From enrollment to the end of treatment at 8 weeks"
MMP-2	MMP-2 was evaluate based on immunohistochemistry by using punch biopsy of anterior vaginal mucosa during and post surgery	From enrollment to the end of treatment at 8 weeks"
MMP-9	MMP-9 are evaluate based on immunohistochemistry from anterior vaginal wall biopsy during and post operative	From enrollment to the end of treatment at 8 weeks"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor muscle strength	Pelvic floor muscle strength was analyse using biofeedback	From enrollment to the end of treatment at 8 weeks"
Pelvic organ prolapse recurrency	Pelvic organ prolapse recurrency are evaluate based on POP Q system	From enrollment to the end of treatment at 8 weeks"

Collaborators and Investigators

• Sponsor: Andalas University
• Collaborators: Faculty of Medicine, Andalas University; Dr. M Djamil Hospital, Padang
• Investigators: 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 Director: Aisyah Elliyanti, Prof, PhD, MD, Biomedical Science Doctoral Programme Faculty of Medicine Andalas University; Study Chair: Bobby Indra, Utama, MD, PhD, Biomedical Science Doctoral Programme Faculty of Medicine Andalas University; Study Chair: Zelly Dia, Rofinda, MD, PhD, Biomedical Science Doctoral Programme Faculty of Medicine Andalas University

Publications and helpful links

Helpful Links

• Research protocol
• Research Informed consent

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 25, 2025
• First Submitted That Met QC Criteria: August 25, 2025
• First Posted (Estimated): September 2, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; MMP-9; MMP-2; Pelvic organ prolapse surgery; Platelet rich plasma injection; Type I/III collagen ratio
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: DP.04.03/D.XIV.10.1/301/2025 (Other Identifier: Health Research Ethic Committee M Djamil Hospital Padang Indonesia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: informed consent should be taken from the patient to share the data

Study Data/Documents

1. Study Protocol
   Information comments: https://bit.ly/45NuVGB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No