Telerehabilitation for Overactive Bladder Syndrome in Obese Women

Not Applicable

Recruiting

• Conditions: Overactive Bladder Syndrome
• Interventions: Other: Pilates exercises; Behavioral: Mediterranean diet

• Registration Number: NCT06045728
• Lead Sponsor: Cairo University

Brief Summary

Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and to compare between the telerehabilitation group and the control group regarding overactive bladder symptoms and metabolic health in obese women.

Detailed Description

overactive bladder syndrome occurs globally and affects both genders with studies indicating high prevalence in obese females. Obesity brings with it not only an increased risk of cardiovascular diseases, but also urological dysfunction including overactive bladder. Pilates exercise and diet can be used as ways for controlling overactive bladder symptoms and improving overall health of obese subjects. Integration of telerehabilitation in the clinical practice benefits both providers and patients as well decreasing healthcare costs, so the objective of this study to determine the effect of telerehabilitation on overactive bladder symptoms and metabolic health in obese women through Pilates exercise and Mediterranean diet .

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study Start: 2023-09-15
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• women aged 35-45 years old
• class I obesity(30-34.9kg/m2)
• women will be referred by urologist with Presence of overactive bladder symptoms confirmed by overactive bladder questionnaire
• waist circumference more than 88 cm

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Exclusion Criteria

• history of surgical treatment of urological disease
• infection of urinary tract
• oncological and neurological urinary tract disease,
• refusal to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1 telerehabilitation group	Mediterranean diet	subjects in this group will receive telerehabilitation sessions through online video programs (including Pilates exercise and diet) 3 times per week for 12 weeks. Outcome measures will be evaluated at baseline and after 12 weeks
group 2 control group	Pilates exercises	subjects in this group will be informed about the importance of Pilates exercise and diet for one session only. subjects will be asked to apply the exercise at home 3 times per week for 12 weeks and diet. Outcome measures will be evaluated at baseline and after 12 weeks
group 1 telerehabilitation group	Pilates exercises	subjects in this group will receive telerehabilitation sessions through online video programs (including Pilates exercise and diet) 3 times per week for 12 weeks. Outcome measures will be evaluated at baseline and after 12 weeks
group 2 control group	Mediterranean diet	subjects in this group will be informed about the importance of Pilates exercise and diet for one session only. subjects will be asked to apply the exercise at home 3 times per week for 12 weeks and diet. Outcome measures will be evaluated at baseline and after 12 weeks

Primary Outcome Measures

Name	Time	Method
waist circumference	at baseline and after 12 weeks of the intervention	it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females
overactive bladder questionnaire short form	at baseline and after 12 weeks of the intervention	is a questionnaire that is divided into two sections : symptoms and quality of life. In symptoms section, the higher the scores the more the symptoms that bother the patients. higher scores in quality of life section indicates better quality of life.
patient perception of intensity of urgency scale	at baseline and after 12 weeks of the intervention	a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency
HOMA IR	at baseline and after 12 weeks of the intervention	The homeostatic model assessment (HOMA IR) is a method used to quantify insulin resistance . derived from the product of the insulin and glucose values divided by a constant.
body mass index	at baseline and after 12 weeks of the intervention	it is calculated by dividing weight in kg on height in m square

Secondary Outcome Measures

Name	Time	Method
telehealth usability questionnaire	after 12 weeks of the intervention	a comprehensive questionnaire that covers all usability factors (i.e., usefulness, ease of use, effectiveness, reliability, and satisfaction). It is used with various types of telehealth systems, including the traditional videoconferencing systems, computer-based systems, and the mobile telehealth systems.

Trial Locations

Locations (1)

Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital); 🇪🇬 Giza, Egypt