Lower Urinary Tract SymptomsNCT06070675
Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
A study testing Minze Diary Pod and Paper bladder diary in people with Lower Urinary Tract Symptoms and Voiding Disorders, run by Universiteit Antwerpen at 5 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Lower Urinary Tract Symptoms, Voiding Disorders, Enuresis
- What is being tested?
- Minze Diary Pod and Paper bladder diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesBelgium
- Study dates
- 1 Oct 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Change in urologic treatment during the data collection period
- Inability to hold the Diary Pod while urinating
- Inability to speak, read and write Dutch
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
Privé praktijk dr. Katrien Klockaerts
Aalst, Oost-Vlaanderen, 9300
Katrien Klockaerts
Katrien Klockaerts
- Recruiting
ZNA Koningin Paola Kinderziekenhuis
Antwerp, 2020
An Bael
An Bael
- Recruiting
Imelda Ziekenhuis
Bonheiden, Antwerp, 2820
Hendrik-Jan Florin
Hendrik-Jan Florin
- Recruiting
UZA
Edegem, Antwerpen, 2650
Gunter De Win
Karen De Baets
- Recruiting
AZ Voorkempen
Malle, Antwerpen, 2390
Karolien De Moerloose
Karolien De Moerloose
About this study
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.
Read the 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.
- Being tested
- Minze Diary Pod, Paper bladder diary
- Medical subject headings
- Lower Urinary Tract Symptoms, Enuresis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minze Diary PodDevice
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.
Paper bladder diaryOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Paper bladder diary (pBD) | Other | Patients will complete the paper bladder diary at home for at least 2 consecutive days. Receives: 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. Receives: Device: Minze Diary Pod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 1.5 year
Secondary outcomes (13)
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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion, an average of 1.5 year
Patient satisfaction
Patient satisfaction will be assessed on usability, ergonomics, and diary preference.
Measured: 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.
Measured: Through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Mixed methods, randomized 2x2 crossover trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lola Bladt, Universiteit Antwerpen
- Investigators
- Gunter De Win, PhD, Principal investigator, UZA/UAntwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070675
- Sponsor's protocol ID
- BUN B3002023000056
- Status last verified
- May 2024
- First submitted
- 18 Sep 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06070675
- Acronym / sponsor ID
- BUN B3002023000056
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods, randomized 2x2 crossover trial
| Arm | Type | Receives |
|---|---|---|
| Paper bladder diary (pBD) | Other | Other: Paper bladder diaryPatients will complete the paper bladder diary at home for at least 2 consecutive days. |
| Automated bladder diary (autoBD) | Other | Device: Minze Diary PodPatients will complete the automated bladder diary (Minze Diary Pod) at home for at least 2 consecutive days. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Change in urologic treatment during the data collection period
- Inability to hold the Diary Pod while urinating
- Inability to speak, read and write Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minze Diary PodThe 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. | Device | Automated bladder diary (autoBD) |
| Paper bladder diaryThe 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 | Paper bladder diary (pBD) |
Primary outcome
Level of agreement average daytime volume (ml)
Time frame: Through study completion, an average of 1.5 year
What are the mean differences and the limits of agreement between the pBD and autoBD for average daytime volume (ml).
13 secondary outcomes
Level of agreement maximum voided volume (ml)
Time frame: Through study completion, an average of 1.5 year
Level of agreement 24h voided volume (ml)
Time frame: Through study completion, an average of 1.5 year
Level of agreement nighttime voided volume (ml)
Time frame: Through study completion, an average of 1.5 year
Level of agreement average daytime volume versus age expected bladder capacity (%)
Time frame: Through study completion, an average of 1.5 year
Level of agreement maximum voided volume versus age expected bladder capacity (%)
Time frame: Through study completion, an average of 1.5 year
Level of agreement nighttime voided volume versus age expected bladder capacity (%)
Time frame: Through study completion, an average of 1.5 year
Level of agreement nighttime voided volume versus 24h voided volume (%)
Time frame: Through study completion, an average of 1.5 year
Level of agreement nighttime voided volume versus daytime voiding frequency
Time frame: Through study completion, an average of 1.5 year
Level of agreement nighttime voided volume versus nighttime voiding frequency
Time frame: Through study completion, an average of 1.5 year
Patient compliance reported by patient
Time frame: Through study completion, an average of 1.5 year
Patient compliance reported by healthcare provided
Time frame: Through study completion, an average of 1.5 year
Patient satisfaction
Time frame: Through study completion, an average of 1.5 year
Healthcare professional satisfaction
Time frame: Through study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunter De Win, PhD principal investigator
UZA/UAntwerpen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minze Diary Pod and Paper bladder diary in people with Lower Urinary Tract Symptoms and Voiding Disorders, run by Universiteit Antwerpen at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lola Bladt, MSc (497848014 ext. +32, lola.bladt@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of agreement average daytime volume (ml) (time frame: Through study completion, an average of 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.