Pelvic Organ Prolapse Vaginal SurgeryNCT07746739
Efficacy of Platelet Rich Plasma on Pelvic Floor Muscle Strength and Recurrence Rate in Pelvic Organ Prolapse Surgery
A study testing POP surgery adjunctive PRP in people with Pelvic Organ Prolapse Vaginal Surgery and Pelvic Organ Prolapse, run by Andalas University at 1 site in Indonesia.
Trial summary
Pelvic organ prolapse (POP) is a common pelvic floor disorder associated with impaired quality of life and considerable postoperative recurrence following native tissue repair. Platelet-rich plasma (PRP) has emerged as a regenerative adjunct to improve tissue healing and surgical outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Platelet Rich Plasma Injection
- What is being tested?
- POP surgery adjunctive PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Inclusion Criteria: women aged ≤65 years with stage II or higher pelvic organ prolapse (POP) who provided written informed consent to participate
Exclusion Criteria:a history of gynecologic malignancy, collagen vascular disease, hematological disorders, or diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Pelvic organ prolapse (POP) is a common pelvic floor disorder associated with impaired quality of life and considerable postoperative recurrence following native tissue repair. Platelet-rich plasma (PRP) has emerged as a regenerative adjunct to improve tissue healing and surgical outcomes.
Objective: To evaluate the effect of adjuvant PRP on pelvic floor muscle A single-blind randomized controlled trial was conducted involving 40 women with stage II or higher POP who were randomly assigned to surgery with adjuvant PRP (n=20) or surgery alone (n=20). Pelvic floor muscle strength was assessed by perineometry, while anatomical outcomes were evaluated using the Pelvic Organ Prolapse Quantification (POP-Q) system 8 weeks postoperatively.
- Conditions
- Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Platelet Rich Plasma Injection
- Being tested
- POP surgery adjunctive PRP, POP surgery adjunctive with placebo ( NaCl Injection)
- Keywords
- pelvic organ prolapse, pelvic floor muscle strength, POP recurrence, prp injection, levatoa ani muscle tone
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POP surgery adjunctive PRPProcedure or surgery
In this RCT participants receive POP surgery with adjunctive PRP injection in anterior vaginal wall approximately 1,5 cm below urethra at Pubocervical Fascia.
Pelvic organ prolapse quantification and assessment of Levator ani muscle tone by using Eden Q biofeedback tool before surgery and 8 weeks postoperative
POP surgery adjunctive with placebo ( NaCl Injection)Procedure or surgery
During POP surgery placebo group receive NaCl injection in Pubocervicalis Fascia at 1,5 cm below urethra
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection | Experimental | Participants in the intervention group underwent standard prolapse surgery with adjuvant platelet-rich plasma administration. The control group underwent identical surgical treatment without PRP.
A five 5 ml PRP injection is injected in 1,5 cm below urethra in pubocervicalis fascia in anterior vaginal wall following POP surgery in intervention group. Meanwhile 5 ml NaCl injection were injected in the same location following POP surgery in control group Receives: Procedure: POP surgery adjunctive PRP |
| Placebo injection | Placebo comparator | in this arm patient who received standard operation procedure was given placebo injection Receives: Procedure: POP surgery adjunctive with placebo ( NaCl Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Strength
Pelvic Floor Muscle strength was assessed by using EDAN q biofeedback. The output were resting tone, quick contraction, contonous contraction and post resting tone.
Measured: From enrollment until post operative evaluation at 8 weeks
Degree of Pelvic Organ Prolapse
Degree of POP is measured by using POPQ assessment. Points Ba, C, and Bp are described degree of cystocele, uterine prolapse and rectocele respectively
Measured: From enrollment to the post operative follow up 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 posted5 Aug 2026
- Study start25 Aug 2025
- Primary completion30 Mar 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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, MD, Principal investigator, M Djamil Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746739
- Sponsor's protocol ID
- DP.04.03/D.XVI.10.1/300/2025
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet Rich Plasma on Pelvic Floor Muscle Strength and Recurrence Rate in Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT07746739
- Acronym / sponsor ID
- DP.04.03/D.XVI.10.1/300/2025
- Conditions
- Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Platelet Rich Plasma Injection
- Keywords
- pelvic organ prolapse, pelvic floor muscle strength, POP recurrence, prp injection, levatoa ani muscle tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Andalas UniversityUniversity, hospital or other
- Collaborators
- Dr. M Djamil Hospital, Padang
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 Aug 2026 (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.
Pelvic organ prolapse (POP) is a common pelvic floor disorder associated with impaired quality of life and considerable postoperative recurrence following native tissue repair. Platelet-rich plasma (PRP) has emerged as a regenerative adjunct to improve tissue healing and surgical outcomes.
Objective: To evaluate the effect of adjuvant PRP on pelvic floor muscle A single-blind randomized controlled trial was conducted involving 40 women with stage II or higher POP who were randomly assigned to surgery with adjuvant PRP (n=20) or surgery alone (n=20). Pelvic floor muscle strength was assessed by perineometry, while anatomical outcomes were evaluated using the Pelvic Organ Prolapse Quantification (POP-Q) system 8 weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Experimental | Procedure: POP surgery adjunctive PRPParticipants in the intervention group underwent standard prolapse surgery with adjuvant platelet-rich plasma administration. The control group underwent identical surgical treatment without PRP. A five 5 ml PRP injection is injected in 1,5 cm below urethra in pubocervicalis fascia in anterior vaginal wall following POP surgery in intervention group. Meanwhile 5 ml NaCl injection were injected in the same location following POP surgery in control group |
| Placebo injection | Placebo comparator | Procedure: POP surgery adjunctive with placebo ( NaCl Injection)in this arm patient who received standard operation procedure was given placebo injection |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 adjunctive PRPIn this RCT participants receive POP surgery with adjunctive PRP injection in anterior vaginal wall approximately 1,5 cm below urethra at Pubocervical Fascia. Pelvic organ prolapse quantification and assessment of Levator ani muscle tone by using Eden Q biofeedback tool before surgery and 8 weeks postoperative | Procedure or surgery | PRP Injection |
| POP surgery adjunctive with placebo ( NaCl Injection)During POP surgery placebo group receive NaCl injection in Pubocervicalis Fascia at 1,5 cm below urethra | Procedure or surgery | Placebo injection |
Primary outcome
Pelvic Floor Muscle Strength
Time frame: From enrollment until post operative evaluation at 8 weeks
Pelvic Floor Muscle strength was assessed by using EDAN q biofeedback. The output were resting tone, quick contraction, contonous contraction and post resting tone.
Degree of Pelvic Organ Prolapse
Time frame: From enrollment to the post operative follow up at 8 weeks
Degree of POP is measured by using POPQ assessment. Points Ba, C, and Bp are described degree of cystocele, uterine prolapse and rectocele respectively
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 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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, MD principal investigator
M Djamil Hospital
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 adjunctive PRP in people with Pelvic Organ Prolapse Vaginal Surgery and Pelvic Organ Prolapse, 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?
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 10 Aug 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. Some participants in this study may receive a placebo. 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?
Pelvic Floor Muscle Strength (time frame: From enrollment until post operative evaluation at 8 weeks). The study lists 2 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 10 Aug 2026.