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NCT06070675

Comparison of a Paper and Automated Bladder Diary in Pediatric Patients

Recruiting now NA Last updated 7 May 2024
What this trial tests

NA trial testing Minze Diary Pod in Lower Urinary Tract Symptoms in 60 participants. Currently enrolling.

Timeline
1 October 2023
Primary endpoint
1 September 2025
1 January 2026

Quick facts

Lead sponsorUniversiteit Antwerpen
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposediagnostic
Enrollment60
Start date1 October 2023
Primary completion1 September 2025
Estimated completion1 January 2026
Sites5 locations across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Universiteit Antwerpen — full company profile →

Who can join

Adults 6 to 12, any sex, with Lower Urinary Tract Symptoms or Voiding Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Lower Urinary Tract Symptoms

Currently open trials in the same condition.

Other Universiteit Antwerpen trials

Trials by the same sponsor.

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Data sources for this page

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