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

Overview

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.

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.