Efficacy of Platelet Rich Plasma on Pelvic Floor Muscle Strength and Recurrence Rate in Pelvic Organ Prolapse Surgery

NCT07746739 | Completed DMC

• 1 other identifier: DP.04.03/D.XVI.10.1/300/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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; Platelet Rich Plasma Injection; Pelvic Organ Prolapse Vaginal Surgery

Keywords

pelvic organ prolapse; pelvic floor muscle strength; POP recurrence; prp injection; levatoa ani muscle tone

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  From enrollment to the post operative follow up at 8 weeks

Study Arms (2)

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

Procedure: POP surgery adjunctive PRP

Placebo injection

PLACEBO COMPARATOR

in this arm patient who received standard operation procedure was given placebo injection

Procedure: POP surgery adjunctive with placebo ( NaCl Injection)

Interventions

POP surgery adjunctive PRP PROCEDURE

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

PRP Injection

POP surgery adjunctive with placebo ( NaCl Injection) PROCEDURE

During POP surgery placebo group receive NaCl injection in Pubocervicalis Fascia at 1,5 cm below urethra

Placebo injection

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Post menopausal women aged less than 65 years old
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Andalas University: lead
• Dr. M Djamil Hospital, Padang: collaborator

Study Sites (1)

M Djamil Hospital

Padang, West Sumatera, 25129, Indonesia

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yulia Margaretta Sari, MD

  M Djamil Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: operator was not masker because the operator know the color of PRP and placebo participants were blinded whether they are given pro or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Urogynecology Division

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 5, 2026
• Study Start: August 25, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

ID (1)