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

Development and Feasibility of the Portuguese Version of the ICIQ-bladder Diary as a Mobile Application

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms (LUTS)

Detailed Description

Lower urinary tract symptoms, including overactive bladder and urinary incontinence, are commonly assessed using bladder diaries. These diaries provide structured information on urinary frequency, voided volumes, fluid intake, urgency episodes, and incontinence events, supporting clinical assessment and treatment monitoring. Paper bladder diaries may be difficult to complete and interpret, which can limit their use in routine clinical practice. Electronic versions may improve completion, data quality, and interpretation efficiency.

This study aims to evaluate the feasibility and acceptance of a Portuguese electronic version of the International Consultation on Incontinence Questionnaire Bladder Diary (ICIQ-Bladder Diary) developed as a mobile application integrated into the My São João App. The electronic diary follows the structure of the validated Portuguese version of the ICIQ-Bladder Diary and records information over a 3-day period, including fluid intake, urinary frequency, voided volumes, urgency, incontinence episodes, and pad use.

The study will be conducted at the Pelvic Floor Rehabilitation Unit of ULS São João as a single-arm feasibility study. Adult participants with overactive bladder and/or urinary incontinence who have previous experience completing paper bladder diaries and who use smartphones in daily life will be recruited consecutively during routine consultations.

At the baseline visit, the investigators will collect demographic and clinical information, including previous experience with smartphone use and health-related mobile applications. Participants will complete condition-specific questionnaires and health-related quality-of-life measures. The investigators will provide training on installation and use of the electronic bladder diary application. Participants will then complete the diary for 3 consecutive days.

At the follow-up visit, the investigators will assess diary completion and collect participant feedback regarding usability, acceptability, and preference for the electronic diary format. Application quality will be evaluated using the Portuguese version of the User Mobile App Rating Scale (uMARS).

The primary objective is to evaluate feasibility, measured by the percentage of participants who completely fill in the diary during the study period. Secondary objectives include evaluation of participant acceptability, usability, and preference regarding the electronic format.

In addition, six physicians with experience interpreting paper bladder diaries will review the electronic reports generated by the application. The physicians will evaluate ease of interpretation, preferences regarding diary format, and suggestions for improvement.

The electronic diary automatically generates structured reports containing clinically relevant variables related to fluid intake, urinary frequency, urgency episodes, incontinence episodes, and pad use. Data are transferred to a secure institutional server. Personal identifiers will be removed before analysis, and access to clinical information will be restricted to the investigators directly involved in participant care.

A sample size of 40 participants was considered adequate for this feasibility study. Statistical analysis will include descriptive analysis of demographic and clinical variables and exploratory subgroup analyses according to clinical and demographic characteristics and smartphone use experience.

The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Participation will be voluntary, and all participants will provide written informed consent before inclusion. The investigators expect that the electronic bladder diary will be feasible and well accepted by both participants and physicians and may support broader use of electronic bladder diaries in clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Susana A Moreira, PMR specialist; Phone Number: +351917210578; Email: s.moreira@ulssjoao.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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.	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: Unidade Local de Saúde São João

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: smartphone; incontinence; mobile app; electronic diary; Bladder diary
• Additional Relevant MeSH Terms: Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lower Urinary Tract Symptoms
• Other Study ID Numbers: ULSSaoJoao

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No