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

NCT07150442 | Recruiting DMC

• 1 other identifier: DP.04.03/D.XIV.10.1/301/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Organ Prolapse Vaginal Surgery; Platelet Rich Plasma Injection

Keywords

Pelvic organ prolapse surgery; Platelet rich plasma injection; Type I/III collagen ratio; MMP-2; MMP-9; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pelvic floor muscle strength

  From enrollment to the end of treatment at 8 weeks"

• Pelvic organ prolapse recurrency

  From enrollment to the end of treatment at 8 weeks"

Study Arms (2)

Group A

EXPERIMENTAL

patient who receive POP surgery and PRP injection

Procedure: POP surgery and PRP injection

Group B

EXPERIMENTAL

patient who receive POP surgery and placebo injection

Procedure: POP surgery and placebo injection

Interventions

POP surgery and PRP injection PROCEDURE

Patient who undergo POP surgery will receive PRP injection

Group A

POP surgery and placebo injection PROCEDURE

patient who receive POP surgery and placebo injection

Group B

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Patients with gynecological malignancies
• Patients with a history of collagen disease
• Patients with blood disorders

Sponsors & Collaborators

• Andalas University: lead
• Faculty of Medicine, Andalas University: collaborator
• Dr. M Djamil Hospital, Padang: collaborator

Study Sites (1)

Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang

Padang, West Sumatera, Indonesia

RECRUITING

Related Links

• Research protocol
• Research Informed consent

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Aisyah Elliyanti, Prof, PhD, MD

  Biomedical Science Doctoral Programme Faculty of Medicine Andalas University

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

Yulia Margaretta Sari Yulia Margaretta, Sari, MD

CONTACT

+6281363462158; yulia_kino@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants are masked in this study. Care provider can not be blind because the operator it self inject PRP , meanwhile PRP have different colour to placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Two group will receive different intervention One group will receive pelvic organ prolapse surgery and Platelet Rich Plasma injection One group will receive pelvic organ prolapse surgery and Placebo injection

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: August 27, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

ID (1)