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NCT06070675
Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
NA trial testing Minze Diary Pod in Lower Urinary Tract Symptoms in 60 participants. Currently enrolling.
1 September 2025
Quick facts
| Lead sponsor | Universiteit Antwerpen |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 1 October 2023 |
| Primary completion | 1 September 2025 |
| Estimated completion | 1 January 2026 |
| Sites | 5 locations across Belgium |
Drugs / interventions tested
- Minze Diary Pod
- Paper bladder diary
Conditions studied
- Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
- Voiding Disorders — all drugs for Voiding Disorders →
- Enuresis — all drugs for Enuresis →
- Overactive Bladder — all drugs for Overactive Bladder →
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.
Verify or expand the search:
- PubMed search for NCT06070675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06070675 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiteit Antwerpen
- Last refreshed: 7 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06070675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing