Comparison of a Paper and Automated Bladder Diary in Pediatric Patients

Universiteit Antwerpen

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms; Enuresis; Overactive Bladder; Voiding Disorders

Treatments: Other: Paper bladder diary; Device: Minze Diary Pod

Study type: Interventional

Funder types: Other

Identifiers

NCT06070675

BUN B3002023000056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Paper bladder diary (pBD)

Other group

Description:

Patients will complete the paper bladder diary at home for at least 2 consecutive days.

Treatment:

Other: Paper bladder diary

Automated bladder diary (autoBD)

Other group

Description:

Patients will complete the automated bladder diary (Minze Diary Pod) at home for at least 2 consecutive days.

Treatment:

Device: Minze Diary Pod