Overactive Bladder Clinical Trial
Official title:
Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 1, 2026 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Privé praktijk dr. Katrien Klockaerts | Aalst | Oost-Vlaanderen |
Belgium | ZNA Koningin Paola Kinderziekenhuis | Antwerpen | |
Belgium | Imelda Ziekenhuis | Bonheiden | Antwerp |
Belgium | UZA | Edegem | Antwerpen |
Belgium | AZ Voorkempen | Malle | Antwerpen |
Lead Sponsor | Collaborator |
---|---|
Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of agreement average daytime volume (ml) | What are the mean differences and the limits of agreement between the pBD and autoBD for average daytime volume (ml). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement maximum voided volume (ml) | What are the mean differences and the limits of agreement between the pBD and autoBD for maximum voided volume (ml). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement 24h voided volume (ml) | What are the mean differences and the limits of agreement between the pBD and autoBD for 24h voided volume (ml). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement nighttime voided volume (ml) | What are the mean differences and the limits of agreement between the pBD and autoBD for nighttime voided volume (ml). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement average daytime volume versus age expected bladder capacity (%) | What are the mean differences and the limits of agreement between the pBD and autoBD for average daytime volume versus age expected bladder capacity (%). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement maximum voided volume versus age expected bladder capacity (%) | What are the mean differences and the limits of agreement between the pBD and autoBD for maximum voided volume versus age expected bladder capacity (%). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement nighttime voided volume versus age expected bladder capacity (%) | What are the mean differences and the limits of agreement between the pBD and autoBD for nighttime voided volume versus age expected bladder capacity (%). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement nighttime voided volume versus 24h voided volume (%) | What are the mean differences and the limits of agreement between the pBD and autoBD for nighttime voided volume versus 24h voided volume (%). | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement nighttime voided volume versus daytime voiding frequency | What are the mean differences and the limits of agreement between the pBD and autoBD for nighttime voided volume versus daytime voiding frequency. | Through study completion, an average of 1.5 year | |
Secondary | Level of agreement nighttime voided volume versus nighttime voiding frequency | What are the mean differences and the limits of agreement between the pBD and autoBD for nighttime voided volume versus nighttime voiding frequency. | Through study completion, an average of 1.5 year | |
Secondary | Patient compliance reported by patient | Subjective compliance will be assessed using topics such as completion, reliability, time to data entry, measuring accuracy, child involvement, child's and parents' motivation and interference with daily life. | Through study completion, an average of 1.5 year | |
Secondary | Patient compliance reported by healthcare provided | Subjective compliance will be assessed using topics such as completion, measuring accuracy, quality, reliability and clinical usefulness | Through study completion, an average of 1.5 year | |
Secondary | Patient satisfaction | Patient satisfaction will be assessed on usability, ergonomics, and diary preference. | Through study completion, an average of 1.5 year | |
Secondary | Healthcare professional satisfaction | Healthcare professional satisfaction will be assessed on user experience related to setting up and interpreting the diaries and diary preference.
Healthcare professional satisfaction will be assessed on user experience related to setting up and interpreting the diaries and diary preference. |
Through study completion, an average of 1.5 year |
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