Telerehabilitation for Overactive Bladder Syndrome in Obese Women

Effect of Telerehabilitation on Overactive Bladder Symptoms and Metabolic Health in Obese Women

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Other: Pilates exercises; Behavioral: Mediterranean diet

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: salma I alghitany, phd; Phone Number: 01229723881; Email: fardreams@yahoo.com
• Study Contact Backup: Name: sandra A girguis, PHD; Phone Number: 0122142663; Email: sandra_sweety@hotmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital)
    • Contact: salma I alghitany, phd; Phone Number: 01229723881; Email: fardreams@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 telerehabilitation group; 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	Other: Pilates exercises; 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.; Behavioral: Mediterranean diet; 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.
Other: group 2 control group; 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	Other: Pilates exercises; 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.; Behavioral: Mediterranean diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	it is calculated by dividing weight in kg on height in m square	at baseline and after 12 weeks of the intervention
waist circumference	it is an indicator of central obesity with waist circumference more than 88 cm is considered central obesity in females	at baseline and after 12 weeks of the intervention
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.	at baseline and after 12 weeks of the intervention
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	at baseline and after 12 weeks of the intervention
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.	at baseline and after 12 weeks of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after 12 weeks of the intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: salma I alghitany, PHD, Cairo University

Publications and helpful links

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Syndrome
• Other Study ID Numbers: P.T.REC/012/004621

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No