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OpenTrials
Completed

NCT Number: NCT07150442

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Padang, West Sumatera, Indonesia

About this study

  • Prepare tools and materials for the research.
  • Align perceptions with the research team to conduct well-guided interviews.
  • 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.
  • 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.
  • Randomization of study subjects will be performed.
  • Participants are unaware of whether they would receive PRP therapy or a placebo.
  • The study subjects were hospitalized in preparation for surgery, in accordance with the regulations of the hospital where the study subjects were located.
  • 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.
  • Participant undergo pelvic organ prolapse surgery as a medically indicated treatment for pelvic organ prolapse.
  • 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.
  • 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.
  • The PRP preparation was placed in a 5 cc syringe.
  • The placebo preparation, containing NaCl solution, was placed in a 5 cc syringe.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

POP surgery and PRP injection

Procedure

Patient who undergo POP surgery will receive PRP injection

POP surgery and placebo injection

Procedure

patient who receive POP surgery and placebo injection

Primary outcomes

  1. Type I/III collagen ratio

    Time frame: From enrollment to the end of treatment at 8 weeks"

    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

  2. MMP-2

    Time frame: From enrollment to the end of treatment at 8 weeks"

    MMP-2 was evaluate based on immunohistochemistry by using punch biopsy of anterior vaginal mucosa during and post surgery

  3. MMP-9

    Time frame: From enrollment to the end of treatment at 8 weeks"

    MMP-9 are evaluate based on immunohistochemistry from anterior vaginal wall biopsy during and post operative

Secondary outcomes

  1. Pelvic floor muscle strength

    Time frame: From enrollment to the end of treatment at 8 weeks"

    Pelvic floor muscle strength was analyse using biofeedback

  2. Pelvic organ prolapse recurrency

    Time frame: From enrollment to the end of treatment at 8 weeks"

    Pelvic organ prolapse recurrency are evaluate based on POP Q system

Sponsors and collaborators

Lead sponsor

Andalas University

Other

Collaborators

  • Dr. M Djamil Hospital, Padang

Registry information

Acronym: POP PRP MMP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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