Comparison of a Paper and Automated Bladder Diary in Pediatric Patients

NCT06070675 | Recruiting

• 1 other identifier: BUN B3002023000056
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Lower Urinary Tract Symptoms; Voiding Disorders; Enuresis; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Level of agreement maximum voided volume (ml)

  Through study completion, an average of 1.5 year

• Level of agreement 24h voided volume (ml)

  Through study completion, an average of 1.5 year

• Level of agreement nighttime voided volume (ml)

  Through study completion, an average of 1.5 year

• Level of agreement average daytime volume versus age expected bladder capacity (%)

  Through study completion, an average of 1.5 year

• Level of agreement maximum voided volume versus age expected bladder capacity (%)

  Through study completion, an average of 1.5 year

Study Arms (2)

Paper bladder diary (pBD)

OTHER

Patients will complete the paper bladder diary at home for at least 2 consecutive days.

Other: Paper bladder diary

Automated bladder diary (autoBD)

OTHER

Patients will complete the automated bladder diary (Minze Diary Pod) at home for at least 2 consecutive days.

Device: Minze Diary Pod

Interventions

Minze Diary Pod DEVICE

The automated bladder diary utilized in this study consists of the Minze Diary Pod and Minze Flow app. The Diary Pod is a capacitance-based measuring device, that automatically registers voided volumes and time of void. The Diary Pod connects via Bluetooth to the Minze Flow app to request additional information from the patient, such as urge, drinks and leakages.

Automated bladder diary (autoBD)

Paper bladder diary OTHER

The paper bladder diary utilized in this study is a paper timetable that has the patient enter (in the columns of the timetable) drinks in ml, urinations in ml (using a measuring cup) and leakage episodes for the nearest hours (rows of the timetable).

Paper bladder diary (pBD)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Change in urologic treatment during the data collection period
• Inability to hold the Diary Pod while urinating
• Inability to speak, read and write Dutch

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (5)

UZA

Edegem, Antwerpen, 2650, Belgium

RECRUITING

AZ Voorkempen

Malle, Antwerpen, 2390, Belgium

RECRUITING

Imelda Ziekenhuis

Bonheiden, Antwerp, 2820, Belgium

RECRUITING

Privé praktijk dr. Katrien Klockaerts

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

ZNA Koningin Paola Kinderziekenhuis

Antwerp, 2020, Belgium

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Enuresis; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urinary Bladder Diseases

Study Officials

• Gunter De Win, PhD

  UZA/UAntwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lola Bladt, MSc

CONTACT

497848014; lola.bladt@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Model Details: Mixed methods, randomized 2x2 crossover trial

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 6, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)