Efficacy of Platelet Rich Plasma on Pelvic Floor Muscle Strength and Recurrence Rate in Pelvic Organ Prolapse Surgery
NCT07746739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-08-10
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 Vaginal Surgery
- Pelvic Organ Prolapse
- Platelet Rich Plasma Injection
Interventions
- PROCEDURE
-
POP surgery adjunctive PRP
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
- PROCEDURE
-
POP surgery adjunctive with placebo ( NaCl Injection)
During POP surgery placebo group receive NaCl injection in Pubocervicalis Fascia at 1,5 cm below urethra
Sponsors & Collaborators
-
Dr. M Djamil Hospital, Padang
collaborator UNKNOWN -
Andalas University
lead OTHER
Principal Investigators
-
Yulia Margaretta Sari, MD · M Djamil Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-25
- Primary Completion
- 2026-03-30
- Completion
- 2026-04-30
Countries
- Indonesia
Study Locations
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