NCT06070675

Comparison of a Paper and Automated Bladder Diary in Pediatric Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare an automated bladder diary (autoBD) to a paper bladder diary (pBD) on their level of agreement, patient compliance and satisfaction. It is a mixed methods, randomized 2x2 crossover trial. Pediatric patients (6 to 12 years) presenting to the clinic and identified as requiring a bladder diary will be recruited. Participants will be randomized either to group 1, where they complete the paper bladder diary (pBD) and then the automated bladder diary (autoBD), or to group 2, where they complete the autoBD and then the pBD. Both diaries are kept for at least 2 consecutive days with a wash-out period of 2 to 6 days between the two diaries. Mean differences and the level of agreement between the pBD and autoBD will be analysed using Bland Altman plots for key diary parameters. After completion of each diary format, participants will complete a short online survey regarding compliance, satisfaction and their preference, if any. Finally, a selection of participants and their parents will be invited for an open-ended interview. The participating healthcare professionals will be asked to score each pBD and autoBD on patient compliance when processing the diary. Furthermore, surveys and open-ended interviews will be conducted to assess their overall satisfaction of each diary type and their preference, if any.

Detailed description

For some time now, patient compliance with paper bladder diaries is being questioned. Paper bladder diaries are often incomplete, unreliable and/or of low quality. Multiple electronic bladder diaries have been developed to overcome some of the limitations associated with paper bladder diaries. However, based on several comparison studies between paper and electronic bladder diaries, it is not clear whether an electronic format alone is truly superior to the paper format. The investigators want to introduce and evaluate the feasibility of a new type of bladder diary: an automated bladder diary. In contrast to an electronic diary, an automated diary automatically registers voiding data using a connected measuring device. An electronic diary simply eliminates the use of paper, but the patient still needs to measure the voided volumes with a urinary container and manually enter them in the electronic diary. The investigators believe an automated diary may lead to improved patient compliance by reducing the required efforts from the patient and instead provide guidance and prompts.

Conditions

• Lower Urinary Tract Symptoms
• Voiding Disorders
• Enuresis
• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Minze Diary Pod	The automated bladder diary utilized in this study consists of the Minze Diary Pod and Minze Flow app. The Diary Pod is a capacitance-based measuring device, that automatically registers voided volumes and time of void. The Diary Pod connects via Bluetooth to the Minze Flow app to request additional information from the patient, such as urge, drinks and leakages.
OTHER	Paper bladder diary	The paper bladder diary utilized in this study is a paper timetable that has the patient enter (in the columns of the timetable) drinks in ml, urinations in ml (using a measuring cup) and leakage episodes for the nearest hours (rows of the timetable).

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-09-01
• Completion: 2026-01-01
• First posted: 2023-10-06
• Last updated: 2024-05-07

Locations

5 sites across 1 country: Belgium