Clinical trial NCT06070675: Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
Official title: Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Voiding Disorders
Enuresis
Overactive Bladder
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Mixed methods, randomized 2x2 crossover trial
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of agreement average daytime volume (ml)
timeFrame: Through study completion, an average of 1.5 year
Secondary outcomes:
measure: Level of agreement maximum voided volume (ml)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement 24h voided volume (ml)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement nighttime voided volume (ml)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement average daytime volume versus age expected bladder capacity (%)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement maximum voided volume versus age expected bladder capacity (%)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement nighttime voided volume versus age expected bladder capacity (%)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement nighttime voided volume versus 24h voided volume (%)
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement nighttime voided volume versus daytime voiding frequency
timeFrame: Through study completion, an average of 1.5 year
measure: Level of agreement nighttime voided volume versus nighttime voiding frequency
timeFrame: Through study completion, an average of 1.5 year
measure: Patient compliance reported by patient
timeFrame: Through study completion, an average of 1.5 year
measure: Patient compliance reported by healthcare provided
timeFrame: Through study completion, an average of 1.5 year
measure: Patient satisfaction
timeFrame: Through study completion, an average of 1.5 year
measure: Healthcare professional satisfaction
timeFrame: Through study completion, an average of 1.5 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
state: Antwerpen
city: Malle
country: Belgium
facility: AZ Voorkempen
state: Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
state: Antwerp
city: Aalst
country: Belgium
facility: Privé praktijk dr. Katrien Klockaerts
state: Oost-Vlaanderen
city: Antwerpen
country: Belgium
facility: ZNA Koningin Paola Kinderziekenhuis
Study officials:
affiliation: UZA/UAntwerpen
name: Gunter De Win, PhD
role: PRINCIPAL_INVESTIGATOR
References: