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临床试验/NCT06137326
NCT06137326已完成不适用

Efficacy of Pulsed Electromagnetic Field Therapy Versus Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial

Ahram Canadian University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in pelvic floor muscle strength

研究概览

简要总结

Stress urinary incontinence, or involuntary urine leakage during activities like coughing, laughing, or exercise, is a common condition that impacts quality of life for many women. Pelvic floor muscle training is often used to treat stress incontinence, but additional therapies may enhance outcomes. This randomized controlled trial will compare two physical therapy modalities, pulsed electromagnetic field (PEMF) therapy versus laser acupuncture, along with pelvic floor training for improving stress urinary incontinence in 60 adult women. The study will evaluate their effects on pelvic floor muscle strength, severity of urine leakage, and quality of life. We hypothesize that PEMF and laser acupuncture will both improve stress incontinence, but PEMF will be more effective based on greater pelvic floor stimulation. The study aims to provide evidence on these physical therapy options so that optimized treatment plans can be developed for women with stress urinary incontinence.

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 (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult females aged 18-65 years with stress urinary incontinence
  • Able to comply with study procedures and schedule

排除标准

  • Prior pelvic floor surgery
  • Pregnancy
  • Active urinary tract infection
  • Pelvic organ prolapse >Stage 2
  • Neurologic disorder affecting urinary function

结局指标

主要结局

Change in pelvic floor muscle strength

时间窗: Baseline and 8 weeks

elvic floor muscle strength will be assessed using a calibrated perineometer device that measures vaginal squeeze pressure. Strength will be recorded in cm H2O.

次要结局

  • Change in ICIQ-UI SF score(Baseline and 8 weeks)
  • Change in Severity Index for urinary incontinence(Baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Magdy ElMeligie

Director of Electromyography lab

Ahram Canadian University

研究点 (2)

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