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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-27

Study Completion Date

2026-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse Vaginal Surgery Platelet Rich Plasma Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Group A

patient who receive POP surgery and PRP injection

Group Type EXPERIMENTAL

POP surgery and PRP injection

Intervention Type PROCEDURE

Patient who undergo POP surgery will receive PRP injection

Group B

patient who receive POP surgery and placebo injection

Group Type EXPERIMENTAL

POP surgery and placebo injection

Intervention Type PROCEDURE

patient who receive POP surgery and placebo injection

Interventions

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POP surgery and PRP injection

Patient who undergo POP surgery will receive PRP injection

Intervention Type PROCEDURE

POP surgery and placebo injection

patient who receive POP surgery and placebo injection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Yulia Margaretta Sari

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yulia Margaretta Sari Yulia Margaretta, Sari, MD, MD

Role: PRINCIPAL_INVESTIGATOR

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