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Telerehabilitation for Overactive Bladder Syndrome in Obese Women

Primary Purpose

Overactive Bladder Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pilates exercises
Mediterranean diet
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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 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

Sites / Locations

  • Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

group 1 telerehabilitation group

group 2 control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

body mass index
it is calculated by dividing weight in kg on height in m square
waist circumference
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
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
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
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.

Secondary Outcome Measures

telehealth usability questionnaire
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.

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06045728
Brief Title
Telerehabilitation for Overactive Bladder Syndrome in Obese Women
Official Title
Effect of Telerehabilitation on Overactive Bladder Symptoms and Metabolic Health in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
For insulin resistance the investigator will not know which group will be assessed
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1 telerehabilitation group
Arm Type
Active Comparator
Arm Description
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
Arm Title
group 2 control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Intervention Description
Pilates is a group of low impact muscle exercises that strengthen abdominal muscles, back, hips and pelvic floor muscles. the exercise consists of 10 min warm up, 40 min exercise and 10 min cooling down. the exercises that will be included: spine twist, double leg stretch, double leg circles, side leg circle, curl up, shoulder bridges and pelvic curl.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet
Intervention Description
it is a type of diet used for obesity management based on high vegetable intake, olive oil as a source of fat, the consumption of grains, legumes, and nuts with high amounts of pulp, low-medium consumption of fish, low consumption of red meat.
Primary Outcome Measure Information:
Title
body mass index
Description
it is calculated by dividing weight in kg on height in m square
Time Frame
at baseline and after 12 weeks of the intervention
Title
waist circumference
Description
it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females
Time Frame
at baseline and after 12 weeks of the intervention
Title
overactive bladder questionnaire short form
Description
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.
Time Frame
at baseline and after 12 weeks of the intervention
Title
patient perception of intensity of urgency scale
Description
a scale ranges from 0 to 4 that measures the degree of urgency with micturition with higher scores indicate higher perception of urgency
Time Frame
at baseline and after 12 weeks of the intervention
Title
HOMA IR
Description
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.
Time Frame
at baseline and after 12 weeks of the intervention
Secondary Outcome Measure Information:
Title
telehealth usability questionnaire
Description
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.
Time Frame
after 12 weeks of the intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
because prevalence of overactive bladder symptoms in obese women is high
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
salma I alghitany, PHD
Phone
01229723881
Email
fardreams@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sandra A girguis, PHD
Phone
0122142663
Email
sandra_sweety@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
salma I alghitany, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital)
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
salma I alghitany, phd
Phone
01229723881
Email
fardreams@yahoo.com

12. IPD Sharing Statement

Links:
URL
https://doi.org/10.1016/j.urology.2018.09.012
Description
Relationship Between Central Obesity, General Obesity, Overactive Bladder Syndrome and Urinary Incontinence Among Male and Female Patients Seeking Care for Their Lower Urinary Tract Symptoms

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Telerehabilitation for Overactive Bladder Syndrome in Obese Women

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