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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05347472
Other study ID # 20210408
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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