Pelvic Organ Prolapse Vaginal SurgeryPOP PRP MMPNCT07150442
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
A study testing POP surgery and PRP injection in people with Pelvic Organ Prolapse Vaginal Surgery and Platelet Rich Plasma Injection, run by Andalas University at 1 site in Indonesia.
Trial 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?… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse Vaginal Surgery, Platelet Rich Plasma Injection
- What is being tested?
- POP surgery and PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Aug 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with gynecological malignancies
- Patients with a history of collagen disease
- Patients with blood disorders
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Biomedical Science Doctoral Programme Faculty of Medicine Andalas University/ Urogynecology Division Obstetrics and Gynecology Department M Djamil Hospital Padang
Padang, West Sumatera
About this study
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:
Read more
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.
- Being tested
- POP surgery and PRP injection, POP surgery and placebo injection
- Keywords
- Pelvic organ prolapse surgery, Platelet rich plasma injection, Type I/III collagen ratio, MMP-2, MMP-9, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POP surgery and PRP injectionProcedure or surgery
Patient who undergo POP surgery will receive PRP injection
POP surgery and placebo injectionProcedure or surgery
patient who receive POP surgery and placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | patient who receive POP surgery and PRP injection Receives: Procedure: POP surgery and PRP injection |
| Group B | Experimental | patient who receive POP surgery and placebo injection Receives: Procedure: POP surgery and placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks"
Secondary outcomes (2)
Pelvic floor muscle strength
Pelvic floor muscle strength was analyse using biofeedback
Measured: 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
Measured: From enrollment to the end of treatment at 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start25 Aug 2025
- Primary completion31 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse Vaginal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalas University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. M Djamil Hospital, Padang
- Responsible party
- Principal investigator, Yulia Margaretta Sari, Andalas University
- Investigators
- 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 IndonesiaAisyah Elliyanti, Prof, PhD, MD, Study director, Biomedical Science Doctoral Programme Faculty of Medicine Andalas UniversityBobby Indra, Utama, MD, PhD, Study chair, Biomedical Science Doctoral Programme Faculty of Medicine Andalas UniversityZelly Dia, Rofinda, MD, PhD, Study chair, Biomedical Science Doctoral Programme Faculty of Medicine Andalas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150442
- Sponsor's protocol ID
- DP.04.03/D.XIV.10.1/301/2025
- Other IDs
- DP.04.03/D.XIV.10.1/301/2025
- Acronym
- POP PRP MMP
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: informed consent should be taken from the patient to share the data
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07150442
- Acronym / sponsor ID
- POP PRP MMP / DP.04.03/D.XIV.10.1/301/2025
- Keywords
- Pelvic organ prolapse surgery, Platelet rich plasma injection, Type I/III collagen ratio, MMP-2, MMP-9, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Andalas UniversityUniversity, hospital or other
- Collaborators
- Dr. M Djamil Hospital, Padang
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: POP surgery and PRP injectionpatient who receive POP surgery and PRP injection |
| Group B | Experimental | Procedure: POP surgery and placebo injectionpatient who receive POP surgery and placebo injection |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with gynecological malignancies
- Patients with a history of collagen disease
- Patients with blood disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POP surgery and PRP injectionPatient who undergo POP surgery will receive PRP injection | Procedure or surgery | Group A |
| POP surgery and placebo injectionpatient who receive POP surgery and placebo injection | Procedure or surgery | Group B |
Primary outcome
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
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
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
2 secondary outcomes
Pelvic floor muscle strength
Time frame: From enrollment to the end of treatment at 8 weeks"
Pelvic organ prolapse recurrency
Time frame: From enrollment to the end of treatment at 8 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Research protocolLink provided by the sponsor.
- Research Informed consentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. informed consent should be taken from the patient to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POP surgery and PRP injection in people with Pelvic Organ Prolapse Vaginal Surgery and Platelet Rich Plasma Injection, run by Andalas University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type I/III collagen ratio (time frame: From enrollment to the end of treatment at 8 weeks"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.