Comparing paper and automated bladder diaries in children
Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
NA · Universiteit Antwerpen · NCT06070675
This study tests whether kids aged 6 to 12 find it easier and more satisfying to use an automated bladder diary compared to a traditional paper one.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Universiteit Antwerpen (other) |
| Locations | 5 sites (Edegem, Antwerpen and 4 other locations) |
| Trial ID | NCT06070675 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an automated bladder diary compared to a traditional paper bladder diary in pediatric patients aged 6 to 12 years. It employs a mixed methods, randomized 2x2 crossover design where participants will use both diary formats over a period of time, allowing for a direct comparison of compliance, satisfaction, and agreement between the two methods. The study will analyze the data collected using Bland Altman plots to assess the mean differences and level of agreement for key diary parameters. Participants will also provide feedback through an online survey after each diary format.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 6 to 12 years who require a bladder diary for monitoring urinary symptoms.
Not a fit: Patients who are unable to operate a smartphone or tablet, or those with a change in urologic treatment during the study period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient compliance and data accuracy in monitoring bladder symptoms in children.
How similar studies have performed: Previous studies have shown mixed results regarding the superiority of electronic versus paper diaries, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem, Antwerpen and 4 other locations
- UZA — Edegem, Antwerpen, Belgium (RECRUITING)
- AZ Voorkempen — Malle, Antwerpen, Belgium (RECRUITING)
- Imelda Ziekenhuis — Bonheiden, Antwerp, Belgium (RECRUITING)
- Privé praktijk dr. Katrien Klockaerts — Aalst, Oost-Vlaanderen, Belgium (RECRUITING)
- ZNA Koningin Paola Kinderziekenhuis — Antwerp, Belgium (RECRUITING)
Study contacts
- Principal investigator: Gunter De Win, PhD — UZA/UAntwerpen
- Study coordinator: Lola Bladt, MSc
- Email: lola.bladt@uantwerpen.be
- Phone: 497848014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower Urinary Tract Symptoms, Voiding Disorders, Enuresis, Overactive Bladder