Portuguese Mobile App Version of the ICIQ Bladder Diary for Adults With Urinary Symptoms: Development and Feasibility Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnidade Local de Saúde São João

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Patients with LUTS

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month

Secondary outcomes

1

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.

Time frame
1 month
2

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.

Time frame
1 month
3

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.

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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