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Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low caloric diet, ultrasound cavitation,Kegel exercises
Sponsored by
Dina Mohamed Tarek Mansour El-kasrawy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Visceral fat, total body fat, obese female, stress urinary incontinence

Eligibility Criteria

35 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: · 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.

Sites / Locations

  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

kegel exercises

low caloric diet

ultrasound cavitation

Arm Description

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)

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.

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.

Outcomes

Primary Outcome Measures

stress urinary incontinence
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

Secondary Outcome Measures

waist circumference
measure waist circumference in centimeter
Measure weight
Measure weight in kilogram
Measure body mass index
weight and height will be combined to report BMI in kg/m^2

Full Information

First Posted
June 11, 2023
Last Updated
July 11, 2023
Sponsor
Dina Mohamed Tarek Mansour El-kasrawy
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1. Study Identification

Unique Protocol Identification Number
NCT05944484
Brief Title
Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence
Official Title
Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence by EMG and Iciq Questionnaire
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dina Mohamed Tarek Mansour El-kasrawy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Visceral fat, total body fat, obese female, stress urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence
Masking
ParticipantOutcomes Assessor
Masking Description
Double (participant,outcomes Assessor) Random generator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kegel exercises
Arm Type
Active Comparator
Arm Description
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)
Arm Title
low caloric diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ultrasound cavitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
low caloric diet, ultrasound cavitation,Kegel exercises
Intervention Description
low caloric diet (800-1200) calories/day,). According to each patient, diet contained (carbohydrate protein, fats, minerals, vitamins). 50 to 55% of total calories are carbohydrates, 10 to 15% of total calories protein. Fat limited to less than about 28% of daily total calories .Women took 1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman allowed to change the types of food to avoid boarding. ultrasound cavitation emits low-frequency ultrasound 40 khz for 30 minutes on abdomen twice/ week with 3 days apart for 12 weeks. kegel exercise: Each woman in the study took the same Kegel exercise program performed the Kegel exercise for 12 weeks (3 sessions per week)
Primary Outcome Measure Information:
Title
stress urinary incontinence
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
waist circumference
Description
measure waist circumference in centimeter
Time Frame
12 weeks
Title
Measure weight
Description
Measure weight in kilogram
Time Frame
12 weeks
Title
Measure body mass index
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Obese female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: · 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.
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence

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