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临床试验/NCT07602413
NCT07602413尚未招募不适用

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

Unidade Local de Saúde São João0 个研究点目标入组 40 人开始时间: 2026年5月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Unidade Local de Saúde São João
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Susana Moreira

Principal investigator

Unidade Local de Saúde São João

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