Clinical trial NCT05347472: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol).
timeFrame: Change from baseline to 4 weeks and 16 weeks
measure: Arabic International Consultation on Incontinence Questionnaire-Urinary
timeFrame: Change from baseline to 4 weeks and 16 weeks
measure: Arabic version of Multidimensional Scale of Perceived Social
timeFrame: Change from baseline to 4 weeks and 16 weeks
Secondary outcomes:
measure: Short Form Health Survey
timeFrame: Change from baseline to 4 weeks and 16 weeks
measure: Depression Anxiety Stress Scales
timeFrame: Change from baseline to 4 weeks and 16 weeks
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: Jordan University of Science and Technology
name: Saddam F Kanaan, PhD
role: PRINCIPAL_INVESTIGATOR
References: