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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Lower Urinary Tract Symptoms; Enuresis; Voiding Disorders
• Intervention / Treatment: Other: Paper bladder diary; Device: Minze Diary Pod

Detailed Description

For some time now, patient compliance with paper bladder diaries is being questioned. Paper bladder diaries are often incomplete, unreliable and/or of low quality. Multiple electronic bladder diaries have been developed to overcome some of the limitations associated with paper bladder diaries. However, based on several comparison studies between paper and electronic bladder diaries, it is not clear whether an electronic format alone is truly superior to the paper format. The investigators want to introduce and evaluate the feasibility of a new type of bladder diary: an automated bladder diary. In contrast to an electronic diary, an automated diary automatically registers voiding data using a connected measuring device. An electronic diary simply eliminates the use of paper, but the patient still needs to measure the voided volumes with a urinary container and manually enter them in the electronic diary. The investigators believe an automated diary may lead to improved patient compliance by reducing the required efforts from the patient and instead provide guidance and prompts.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lola Bladt, MSc; Phone Number: +32 497848014; Email: lola.bladt@uantwerpen.be

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • Recruiting
    • ZNA Koningin Paola Kinderziekenhuis
    • Contact: An Bael
    • Principal Investigator: An Bael
    • Sub-Investigator: Nathalie Segers
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Recruiting
      • Imelda Ziekenhuis
      • Contact: Hendrik-Jan Florin
      • Principal Investigator: Hendrik-Jan Florin
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • UZA
      • Contact: Gunter de Win
      • Sub-Investigator: Karen De Baets
      • Sub-Investigator: Tinne Van Aggelpoel
      • Sub-Investigator: Alexandra Vermandel
      • Principal Investigator: Gunter De Win
    • Malle, Antwerpen, Belgium, 2390
      • Recruiting
      • AZ Voorkempen
      • Contact: Karolien De Moerloose
      • Principal Investigator: Karolien De Moerloose
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Recruiting
      • Privé praktijk dr. Katrien Klockaerts
      • Contact: Katrien Klockaerts
      • Principal Investigator: Katrien Klockaerts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Paper bladder diary (pBD); Patients will complete the paper bladder diary at home for at least 2 consecutive days.	Other: Paper bladder diary; 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).
Other: Automated bladder diary (autoBD); Patients will complete the automated bladder diary (Minze Diary Pod) at home for at least 2 consecutive days.	Device: Minze Diary Pod; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Patient satisfaction	Patient satisfaction will be assessed on usability, ergonomics, and diary preference.	Through study completion, an average of 1.5 year
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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Principal Investigator: Gunter De Win, PhD, UZA/UAntwerpen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Enuresis
• Other Study ID Numbers: BUN B3002023000056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No