Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery, Platelet Rich Plasma Injection
Conditions
Keywords
pelvic organ prolapse, pelvic floor muscle strength, POP recurrence, prp injection, levatoa ani muscle tone
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.
Interventions
PROCEDUREPOP 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
PROCEDUREPOP surgery adjunctive with placebo ( NaCl Injection)
During POP surgery placebo group receive NaCl injection in Pubocervicalis Fascia at 1,5 cm below urethra
Sponsors
Andalas University
Dr. M Djamil Hospital, Padang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
operator was not masker because the operator know the color of PRP and placebo participants were blinded whether they are given pro or placebo
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Strength | 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 | 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 |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORYulia Margaretta Sari, MD
M Djamil Hospital
Outcome results
None listed