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)

Andalas University

Status: Enrolling

Conditions: Pelvic Organ Prolapse Vaginal Surgery; Platelet Rich Plasma Injection

Treatments: Procedure: POP surgery and placebo injection; Procedure: POP surgery and PRP injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07150442

DP.04.03/D.XIV.10.1/301/2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Group A

Experimental group

Description:

patient who receive POP surgery and PRP injection

Treatment:

Procedure: POP surgery and PRP injection

Group B

Experimental group

Description:

patient who receive POP surgery and placebo injection

Treatment:

Procedure: POP surgery and placebo injection