Skip to main content
OpenTrials
Completed

NCT Number: NCT07746739

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Vaginal Surgery Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Platelet Rich Plasma Injection Prolapse

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M Djamil Hospital

Padang, West Sumatera, 25129, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Andalas University

Other

Collaborators

  • Dr. M Djamil Hospital, Padang

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.