RecruitingNot ApplicableNCT06070675

Comparison of a Paper and Automated Bladder Diary in Pediatric Patients

Sponsor

Universiteit Antwerpen

Enrollment

60 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Lower Urinary Tract Symptoms Overactive Bladder Voiding Disorders Enuresis

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.

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria4

Pediatric patients presenting to the clinic and identified as requiring a bladder diary
Age: 6 to 12 years
Sex: male or female
Child and/or parent own and are able to operate a smartphone and/or tablet

Exclusion Criteria3

Change in urologic treatment during the data collection period
Inability to hold the Diary Pod while urinating
Inability to speak, read and write Dutch

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Interventions

DEVICEMinze 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.

OTHERPaper 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).