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

Sponsor

Dina Mohamed Tarek Mansour El-kasrawy (Other)

Overall Status

Completed

CT.gov ID

NCT05944484

Collaborator

(none)

Enrollment

Location

Arms

30.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinenceVisceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double (participant,outcomes Assessor) Random generator

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 30, 2020

Actual Primary Completion Date :

May 5, 2023

Actual Study Completion Date :

Jun 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: kegel exercises 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)	Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises 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)
Active Comparator: low caloric diet 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.	Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises 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)
Active Comparator: ultrasound cavitation 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.	Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises 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)

Arm

Intervention/Treatment

Active Comparator: kegel exercises

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)

Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises

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)

Active Comparator: low caloric diet

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.

Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises

Active Comparator: ultrasound cavitation

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.

Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises

Outcome Measures

Primary Outcome Measures

stress urinary incontinence [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

Secondary Outcome Measures

waist circumference [12 weeks]
measure waist circumference in centimeter
Measure weight [12 weeks]
Measure weight in kilogram
Measure body mass index [12 weeks]
weight and height will be combined to report BMI in kg/m^2

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts 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.