About this trial
The goal of this clinical trial is to evaluate a mobile app version of the International Consultation on Incontinence Questionnaire Bladder Diary (ICIQ-Bladder Diary) in Portuguese adults with urinary symptoms. The study aims to learn whether an electronic bladder diary is feasible, easy to use, and well accepted by participants and physicians.
The main questions it aims to answer are:
Is the mobile app feasible, based on the percentage of participants who completely fill in the diary over 1 month? Do participants consider the app to be high quality and easy to use? Do participants and physicians prefer the electronic diary over paper formats?
Participants will:
Use the mobile app version of the ICIQ-Bladder Diary for 1 month; Complete questionnaires about app quality, usability, and preference, including the User Mobile App Rating Scale (uMARS).
Six rehabilitation physicians will review the completed diaries and answer questions about ease of interpretation and preferred diary format.
The investigators expect the app to be feasible and well accepted by both participants and physicians. If successful, the app may support wider use of electronic bladder diaries in clinical practice in Portugal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Diagnosis of overactive bladder and/or urinary incontinence for at least 6 months
Previous experience completing a paper bladder diary
Own and regularly use a smartphone
Disqualifiers
Unable to understand, read, speak, or write Portuguese
No regular access to the internet during the study period
Unable to use a smartphone application independently
Trial population
Patients with OAB and/or urinary incontinence and experience with paper bladder diary
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Participant diary completion rate
Percentage of participants who complete all required entries in the electronic bladder diary during the study period, assessed using diary data recorded in the mobile application.
Secondary outcomes
Participant preference and usability assessment of bladder diary format
Percentage of participants selecting the electronic or paper bladder diary as easier to use, more convenient, and preferred overall, assessed using a 3-item study-specific questionnaire comparing diary formats.
Participant assessment of mobile application quality using the User Mobile App Rating Scale (uMARS)
Mean total score and subscale scores of the Portuguese version of the User Mobile App Rating Scale (uMARS), assessed after use of the electronic ICIQ-Bladder Diary mobile application. The uMARS is a 20-item questionnaire evaluating mobile app quality across 4 objective quality domains (Engagement, Functionality, Aesthetics, and Information Quality) and 1 subjective quality domain. Items are rated on a 5-point scale from 1 ("Inadequate") to 5 ("Excellent"). Higher scores indicate better perceived app quality and user experience. Questions marked as "Not applicable" are excluded from score calculation.
Physician preference and ease of interpretation of the electronic bladder diary
Percentage of physicians reporting preferences regarding the electronic versus paper bladder diary format and rating ease of interpretation of the electronic diary reports, assessed using a study-specific physician questionnaire.
Locations
Sponsors and contacts
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