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Completed

NCT Number: NCT05944484

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

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

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Key information

Conditions

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

Age range

35 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. stress urinary incontinence

    Time frame: 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 outcomes

  1. waist circumference

    Time frame: 12 weeks

    measure waist circumference in centimeter

  2. Measure weight

    Time frame: 12 weeks

    Measure weight in kilogram

  3. Measure body mass index

    Time frame: 12 weeks

    weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Dina Mohamed Tarek Mansour El-kasrawy

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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