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临床试验/NCT05944484
NCT05944484已完成不适用

Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence by EMG and Iciq Questionnaire

Dina Mohamed Tarek Mansour El-kasrawy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
stress urinary incontinence

研究概览

简要总结

The aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

详细描述

compare the effect of visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

control group: consist of 20 obese women. They will receive Kegel exercises only 3 session/ week for 12 weeks.

Diet group: consist of 20 obese women. They will receive low caloric diet and Kegel exercises 3 session/week for 12 weeks.

Ultrasound cavitation group: consist of 20 obese women. They will receive Kegel exercises 3 session/week and ultrasound cavitation two sessions per week.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double (participant,outcomes Assessor) Random generator

入排标准

年龄范围
35 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • They will be diagnosed with stress urinary incontinence grade≥ 1
  • Their age will range from 35-48 years old.
  • Their body mass index will exceed 29.9 kg/m².
  • Their hip waist ratio will be more than 0.85 cm.
  • They will be multipara >1.

排除标准

  • · Fecal incontinence, urge incontinence, overflow incontinence or functional incontinence or prolapse.
  • Diabetes, asthma, cardiovascular, or renal diseases
  • Taking medication for stress urinary incontinence or hormonal replacement therapy.
  • Gynecological surgeries, or surgeries for obesity.
  • Pregnant women.

结局指标

主要结局

stress urinary incontinence

时间窗: 12 weeks

evaluate stress urinary incontinence by The International Consultation on Incontinence Questionnaire ranged from (0-21) Question items: Frequency or urinary incontinence Amount of leakage Overall impact of urinary incontinence Self-diagnostic item. The ICIQ-UI Short form provides a score ranging from 0-21. With a higher score indicating greater severity of symptoms. The "self-diagnostic" portion of the questionnaire is not given a score

次要结局

  • waist circumference(12 weeks)
  • Measure weight(12 weeks)
  • Measure body mass index(12 weeks)

研究者

发起方
Dina Mohamed Tarek Mansour El-kasrawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dina Mohamed Tarek Mansour El-kasrawy

physiotherapist at EL-AHRAR teaching hospital

Cairo University

研究点 (1)

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