CompletedNCT07150442POP PRP MMPUpdated Jul 28, 2026

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

An interventional study of POP surgery and PRP injection and POP surgery and placebo injection in Pelvic Organ Prolapse Vaginal Surgery and Platelet Rich Plasma Injection, sponsored by Andalas University. Completed at 1 site in Indonesia. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Andalas University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 34
Allocation: Randomized
Ages: 45 Years to 65 Years
Sex: Female

Study 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.

Read the detailed description

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.

Conditions studied

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

In context

Lead sponsor

Andalas University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 34 participants (actual)

Study arms

Experimental
Group A
patient who receive POP surgery and PRP injection
Procedure: POP surgery and PRP injection
Experimental
Group B
patient who receive POP surgery and placebo injection
Procedure: POP surgery and placebo injection

Interventions

ProcedurePOP surgery and PRP injection
Patient who undergo POP surgery will receive PRP injection
ProcedurePOP surgery and placebo injection
patient who receive POP surgery and placebo injection

What researchers measure

Primary outcomes

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

Secondary outcomes

Pelvic floor muscle strength
Pelvic floor muscle strength was analyse using biofeedback
Time frame: 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
Time frame: From enrollment to the end of treatment at 8 weeks"

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: Undecided — informed consent should be taken from the patient to share the data

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07150442
Lead sponsor: Andalas University
Collaborators: Dr. M Djamil Hospital, Padang
Responsible party: Yulia Margaretta Sari (MD, Andalas University) — Principal investigator
First posted: Sep 2, 2025
Start date: Aug 25, 2025
Primary completion: Jan 31, 2026
Completion: Apr 30, 2026
Last update: Jul 28, 2026

Study contacts

Yulia Margaretta Sari Yulia Margaretta, Sari, MD, MD

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

Aisyah Elliyanti, Prof, PhD, MD

study director · Biomedical Science Doctoral Programme Faculty of Medicine Andalas University

Bobby Indra, Utama, MD, PhD

study chair · Biomedical Science Doctoral Programme Faculty of Medicine Andalas University

Zelly Dia, Rofinda, MD, PhD

study chair · Biomedical Science Doctoral Programme Faculty of Medicine Andalas University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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