Efficacy of Platelet Rich Plasma on Pelvic Floor Muscle Strength and Recurrence Rate in Pelvic Organ Prolapse Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pelvic Floor Muscle Strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
operator was not masker because the operator know the color of PRP and placebo participants were blinded whether they are given pro or placebo
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged ≤65 years with stage II or higher pelvic organ prolapse (POP) who provided written informed consent to participate
排除标准
- •a history of gynecologic malignancy, collagen vascular disease, hematological disorders, or diabetes mellitus.
研究组 & 干预措施
PRP Injection
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
干预措施: POP surgery adjunctive PRP (Procedure)
Placebo injection
in this arm patient who received standard operation procedure was given placebo injection
干预措施: POP surgery adjunctive with placebo ( NaCl Injection) (Procedure)
结局指标
主要结局
Pelvic Floor Muscle Strength
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Yulia Margaretta Sari
Head of Urogynecology Division
Andalas University