The Efficacy of Therapeutic Exercises Delivered by Smartphone Application

Urinary Incontinence Clinical Trial

Official title:

The Efficacy of Therapeutic Exercises Delivered by Smartphone Application for Urinary Incontinence Among Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05347472
• Other study ID #: 20210408
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: Jordan University of Science and Technology
• Contact: Saddam F Kanaan, PhD
• Phone: +96227201000
• Email: sfkanaan[@]just.edu.jo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Therapeutic exercise has been shown to be effective in Urinary Incontinence management. However, there is a lack of physiotherapy services provided such necessary treatment. Moreover, mobile applications are becoming popular, and there are limited applications designed to help women with Urinary Incontinence. Consequently, no study investigated the effect of a smartphone application with specific exercises program for Urinary Incontinence management. Therefore, the aim of this study is to determine the effect of a Urinary Incontinence exercises delivered by smartphone application on UI outcomes.

Description:

Urinary incontinence (UI) is a common health disorder among women in Jordan and worldwide. UI affects women's quality of life, mental health symptoms, and social participation. However, limited numbers of women with UI seek help for their problems for many reasons, including lack of rehabilitation services, feelings of shame, and unwillingness to discuss their problems. Therapeutic exercise has been shown to be effective in UI management. However, there is a lack of physiotherapy services provided such necessary treatment. Moreover, mobile applications are becoming popular, and there are limited applications designed to help women with UI. Consequently, no study investigated the effect of a smartphone application with specific exercises program for UI management. Therefore, the aim of the study is to develop an evidence-based therapeutic exercise application for UI and investigate its efficacy on UI clinical outcomes. We hypothesize that patients in the intervention group will have a significantly lower score of International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) , a lower score of perceived stress scale, lower Depression Anxiety and Stress scale (DASS-21) score, a higher score of Multidimensional Scale of Perceived Social Support (MSPSS), a higher Short Form Health Survey (SF-12) score, and a higher score of Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) in comparison to the control group.

A randomized controlled trial design. Sixty women with urinary incontinence will be included in this study. Participants will be randomized to the intervention group who will receive the mobile application (will include general information about UI and exercises) and the intervention group who will receive the sham application (include information about UI only). Outcome measures will include Arabic ICIQ-UI SF to assess the frequency of urinary incontinence, the Arabic version of MSPSS to assess the social support, the Arabic version of (DASS-21) to assess the mental health symptoms, SF-12 to assess the quality of life, and ICIQ-LUTSqol to assess the quality of life of women with UI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with UI, aged between 18-40, ability to read and own and use smartphone applications

Exclusion Criteria:

• Women with no medical diagnosis.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Smartphone application
the smartphone application intervention will consist daily physical therapy exercises program. The application will include all the videos about the exercises and all information about the repetition, frequency, intensity, and position.
• Sham Smartphone application
ham application that includes information and general advice about UI only

Locations

Country	Name	City	State
Jordan	King Abdullah University Hospital	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol).	The questionnaire assesses the quality of life of women with UI.	Change from baseline to 4 weeks and 16 weeks
Primary	Arabic International Consultation on Incontinence Questionnaire-Urinary	Provides measurement of severity of UI and its impact on daily life	Change from baseline to 4 weeks and 16 weeks
Primary	Arabic version of Multidimensional Scale of Perceived Social	Self-report measure of subjectively assessed social support	Change from baseline to 4 weeks and 16 weeks
Secondary	Short Form Health Survey	Measures a person's health-related quality of life	Change from baseline to 4 weeks and 16 weeks
Secondary	Depression Anxiety Stress Scales	Measure the emotional state of depression, anxiety, and stress	Change from baseline to 4 weeks and 16 weeks