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临床试验/NCT04590157
NCT04590157Unknown不适用

Neuromodulation Effect of Laser Acupuncture on Female Stress Urinary Incontinence: A Randomized Controlled Trial

Lama Saad El-Din Mahmoud1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Pelvic floor muscle strength (PFMS)

研究概览

简要总结

background:Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women, as it involves involuntary leakage of urine , the current study was To determine the neuromodulation effect of Laser Therapy on Neurogenic Acupoints in female with stress urinary incontinence (SUI).

详细描述

Thirty women with SUI were randomly divided into two equal groups; the control group received pelvic floor muscle training , while the study group received the same pelvic floor muscle training in addition to laser acupuncture on neurogenic acupoints . The outcome measures were pelvic floor muscle strength (PFMS) , SUI severity assessed by Severity Index (SI) , and Incontinence Questionnaire-Short Form (ICIQ-SF). The outcome measures were assessed pre- and post-rehabilitation program.

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
None

入排标准

年龄范围
30 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age ranged from 30 to 45 years old
  • body mass index (BMI) was less than 30 kg/m2,
  • all women were non-smokers and they had a sedentary life style

排除标准

  • The participants were excluded if they had other types of urinary incontinence (urge or mixed)
  • urinary tract infection
  • pelvic organ prolapse
  • diabetes mellitus
  • respiratory diseases, chronic cough and constipation

结局指标

主要结局

Pelvic floor muscle strength (PFMS)

时间窗: 6 weeks

The pelvic floor muscle strength of all women in both groups was assessed pre- and post-rehabilitation program, using XFT-0010 Pelvic Muscle Trainer device

Stress urinary incontinence (SUI) severity

时间窗: 6 weeks

The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.

International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).

时间窗: 6 weeks

it is a validated subjective measure used to assess the Stress urinary incontinence and its impact on quality of life

次要结局

未报告次要终点

研究者

发起方
Lama Saad El-Din Mahmoud
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lama Saad El-Din Mahmoud

Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

October 6 University

研究点 (1)

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