The Efficacy of Therapeutic Exercises Delivered by Smartphone Application
Primary Purpose
Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Smartphone application
Sham Smartphone application
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- King Abdullah University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
In this group, women will receive the smartphone application intervention that will include daily physical therapy exercises program
In this group, women will receive the sham application that includes information and general advice about UI only
Outcomes
Primary Outcome Measures
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.
Arabic International Consultation on Incontinence Questionnaire-Urinary
Provides measurement of severity of UI and its impact on daily life
Arabic version of Multidimensional Scale of Perceived Social
Self-report measure of subjectively assessed social support
Secondary Outcome Measures
Short Form Health Survey
Measures a person's health-related quality of life
Depression Anxiety Stress Scales
Measure the emotional state of depression, anxiety, and stress
Full Information
NCT ID
NCT05347472
First Posted
April 21, 2022
Last Updated
April 21, 2022
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05347472
Brief Title
The Efficacy of Therapeutic Exercises Delivered by Smartphone Application
Official Title
The Efficacy of Therapeutic Exercises Delivered by Smartphone Application for Urinary Incontinence Among Women: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
In this group, women will receive the smartphone application intervention that will include daily physical therapy exercises program
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
In this group, women will receive the sham application that includes information and general advice about UI only
Intervention Type
Other
Intervention Name(s)
Smartphone application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Smartphone application
Intervention Description
ham application that includes information and general advice about UI only
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol).
Description
The questionnaire assesses the quality of life of women with UI.
Time Frame
Change from baseline to 4 weeks and 16 weeks
Title
Arabic International Consultation on Incontinence Questionnaire-Urinary
Description
Provides measurement of severity of UI and its impact on daily life
Time Frame
Change from baseline to 4 weeks and 16 weeks
Title
Arabic version of Multidimensional Scale of Perceived Social
Description
Self-report measure of subjectively assessed social support
Time Frame
Change from baseline to 4 weeks and 16 weeks
Secondary Outcome Measure Information:
Title
Short Form Health Survey
Description
Measures a person's health-related quality of life
Time Frame
Change from baseline to 4 weeks and 16 weeks
Title
Depression Anxiety Stress Scales
Description
Measure the emotional state of depression, anxiety, and stress
Time Frame
Change from baseline to 4 weeks and 16 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women with UI
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saddam F Kanaan, PhD
Phone
+96227201000
Ext
26940
Email
sfkanaan@just.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddam F Kanaan, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdullah University Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Therapeutic Exercises Delivered by Smartphone Application
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