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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

ConditionsPelvic Organ Prolapse Vaginal SurgeryPlatelet Rich Plasma Injection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorAndalas University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with gynecological malignancies

Patients with a history of collagen disease

Patients with blood disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • POP surgery and PRP injection

    Procedure/Surgery

    Patient who undergo POP surgery will receive PRP injection

  • POP surgery and placebo injection

    Procedure/Surgery

    patient who receive POP surgery and placebo injection

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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"
2

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"
3

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

1

Pelvic floor muscle strength

Pelvic floor muscle strength was analyse using biofeedback

Time frame
From enrollment to the end of treatment at 8 weeks"
2

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"

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andalas University

Lead sponsor

Dr. M Djamil Hospital, Padang

Collaborator

Source ClinicalTrials.gov
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