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

NCT07602413 | Not Yet Recruiting

• 1 other identifier: ULSSaoJoao
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Urinary Tract Symptoms (LUTS)

Keywords

Bladder diary; incontinence; smartphone; mobile app; electronic diary

Outcome Measures

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.

  1 month

Secondary Outcomes (3)

• Participant preference and usability assessment of bladder diary format

  1 month

• Participant assessment of mobile application quality using the User Mobile App Rating Scale (uMARS)

  1 month

• Physician preference and ease of interpretation of the electronic bladder diary

  1 month

Study Arms (1)

Patients with LUTS

Patients with with previous diagnosis of OAB and/or UI and experience with paper bladder diary, consecutively attending rehabilitation consult

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with OAB and/or urinary incontinence and experience with paper bladder diary

You may qualify if:

• 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
• Able to understand and use the My São João App and the Diário da Bexiga VD mobile application
• Able and willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saúde São João: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Susana A Moreira, PMR specialist

CONTACT

+351917210578; s.moreira@ulssjoao.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05