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

NCT05944484 | Completed DMC

• 1 other identifier: Effect of fat on SUI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Visceral fat; total body fat; obese female; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (3)

• waist circumference

  12 weeks

• Measure weight

  12 weeks

• Measure body mass index

  12 weeks

Study Arms (3)

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)

Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises

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.

Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises

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.

Behavioral: low caloric diet, ultrasound cavitation,Kegel exercises

Interventions

low caloric diet, ultrasound cavitation,Kegel exercises 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)

kegel exercises; low caloric diet; ultrasound cavitation

Eligibility Criteria

• Age: 35 Years - 48 Years
• Gender Eligibility Details: Obese female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• · 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.

Sponsors & Collaborators

• Dina Mohamed Tarek Mansour El-kasrawy: lead

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (participant,outcomes Assessor) Random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist at EL-AHRAR teaching hospital

Model Details: Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: July 13, 2023
• Study Start: November 30, 2020
• Primary Completion: May 5, 2023
• Study Completion: June 5, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)