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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
干预措施

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
否

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.

研究组 & 干预措施

kegel exercises

Active Comparator

Kegel exercise program performed for 12 weeks( 3 sessions /week )

.• "The first step is external observation, with the patient in the lithotomy position.And describe for each woman how to feel her muscle when she stops mid-stream urine.

  • "The second step is vaginal examination, performed gently with one finger." - The digital exam served a double purpose: first to assess the development of the puboccocygeus muscle and second to verify that the patient was able to identify the correct muscle
  • The third stage main exercises quick flick : contract muscle as quickly as possible 10-20 times then relax then count 10 for relax then reapeat .( 50 repetitions) slow contraction: tighten the muscle as hard as you can for account of 10 -20 .relax for acount 10 then repeat ( 50 repetitions) sustained contraction: tighten the muscle halfway and hold 60 seconds .relax for account 20 then repeat (10 repetitions)

干预措施: low caloric diet, ultrasound cavitation,Kegel exercises (Behavioral)

low caloric diet

Active Comparator

low caloric diet (800-1200) calories/day . According to each patient, diet should contain (carbohydrate protein, fats, minerals, vitamins),1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman will be allowed to change the types of food to avoid boarding.

干预措施: low caloric diet, ultrasound cavitation,Kegel exercises (Behavioral)

ultrasound cavitation

Active Comparator

ultrasound cavitation, for 30 minutes on abdomen with continuous emission and frequency of 40 KHz, 3-6 W/cm2, 60W with 10cm2 active surface, twice/ week with 3 days apart for 12 weeks.

干预措施: low caloric diet, ultrasound cavitation,Kegel exercises (Behavioral)

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

  • Measure weight(12 weeks)
  • waist circumference(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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