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

NCT ID: NCT05944484

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2023-06-05

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

low caloric diet, ultrasound cavitation,Kegel exercises

Intervention Type: BEHAVIORAL

• 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)

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.

Group Type: ACTIVE_COMPARATOR

low caloric diet, ultrasound cavitation,Kegel exercises

Intervention Type: BEHAVIORAL

• 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)

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.

Group Type: ACTIVE_COMPARATOR

low caloric diet, ultrasound cavitation,Kegel exercises

Intervention Type: BEHAVIORAL

• 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)

Interventions

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)

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dina Mohamed Tarek Mansour El-kasrawy

OTHER

Sponsor Role: lead

Responsible Party

Dina Mohamed Tarek Mansour El-kasrawy

physiotherapist at EL-AHRAR teaching hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of physical therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Effect of fat on SUI

Identifier Type: -

Identifier Source: org_study_id