Telerehabilitation for Overactive Bladder Syndrome in Obese Women

NCT06045728 | Unknown

• 1 other identifier: P.T.REC/012/004621
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• telehealth usability questionnaire

  after 12 weeks of the intervention

Study Arms (2)

group 1 telerehabilitation group

ACTIVE COMPARATOR

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; Behavioral: Mediterranean diet

group 2 control group

OTHER

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; Behavioral: Mediterranean diet

Interventions

Pilates exercises OTHER

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.

group 1 telerehabilitation group; group 2 control group

Mediterranean diet BEHAVIORAL

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.

group 1 telerehabilitation group; group 2 control group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: because prevalence of overactive bladder symptoms in obese women is high
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Giza, Egypt

RECRUITING

Related 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

MeSH Terms

Interventions

Exercise Movement Techniques; Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• salma I alghitany, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

salma I alghitany, PHD

CONTACT

01229723881; fardreams@yahoo.com

sandra A girguis, PHD

CONTACT

0122142663; sandra_sweety@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: For insulin resistance the investigator will not know which group will be assessed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teacher at Faculty of physical therapy Cairo university

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

EG (1)