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临床试验/NCT05347472
NCT05347472已完成不适用

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

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Arabic version of Multidimensional Scale of Perceived Social

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Women with no medical diagnosis.

结局指标

主要结局

Arabic version of Multidimensional Scale of Perceived Social

时间窗: Change from baseline to 4 weeks and 16 weeks

Self-report measure of subjectively assessed social support

International Consultation on Incontinence Modular Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol).

时间窗: Change from baseline to 4 weeks and 16 weeks

The questionnaire assesses the quality of life of women with UI.

Arabic International Consultation on Incontinence Questionnaire-Urinary

时间窗: Change from baseline to 4 weeks and 16 weeks

Provides measurement of severity of UI and its impact on daily life

次要结局

  • Depression Anxiety Stress Scales(Change from baseline to 4 weeks and 16 weeks)
  • Short Form Health Survey(Change from baseline to 4 weeks and 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saddam Kanaan

Associate Professor

Jordan University of Science and Technology

研究点 (2)

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