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

Andalas University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse Vaginal Surgery Pelvic Organ Prolapse Platelet Rich Plasma Injection

POP surgery adjunctive PRPPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: From enrollment to the post operative follow up at 8 weeks