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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05944484
• Other study ID #: Effect of fat on SUI
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: June 5, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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)

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dina Mohamed Tarek Mansour El-kasrawy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	waist circumference	measure waist circumference in centimeter	12 weeks
Secondary	Measure weight	Measure weight in kilogram	12 weeks
Secondary	Measure body mass index	weight and height will be combined to report BMI in kg/m^2	12 weeks