Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000828921
Ethics application status
Approved
Date submitted
4/08/2011
Date registered
5/08/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Watch with Alarm for Timed-voiding in Children (WATCH) Study
Scientific title
A randomised controlled trial comparing the proportion of patients with daytime incontinence cured at 3 months by the personal alarm watch versus a conventional watch to aid timed voiding
Secondary ID [1] 262766 0
None
Universal Trial Number (UTN)
Trial acronym
WATCH Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Daytime urinary incontinence 270476 0
Condition category
Condition code
Renal and Urogenital 270633 270633 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will receive a personalised alarm watch, with the alarm on the watch set to approximately two hourly intervals by the trial coordinator at times defined by the parents to fit in with the child’s daily routine and then “locked” to prevent tampering. Children will be asked to void approximately every 2 hours while awake using their watches to help them.
1. The watch will be set to alarm approximately every 2-3 hours during the day at times defined by parents to fit in with the child’s activities (eg at recess and lunch times). It will not be alarming overnight.
2. The alarm watch will be work daily for the duration of the study treatment period (3 months)
Intervention code [1] 269122 0
Treatment: Devices
Comparator / control treatment
Children will receive an identical watch (with normal time and date set by the trial coordinator). Children will be asked to void approximately every 2 hours while awake using their watches to help them.
Control group
Active

Outcomes
Primary outcome [1] 269361 0
Proportion of patients cured at 3 months measured by a bladder diary
Timepoint [1] 269361 0
Daily recordings of wet/dry days collected every 2 weeks for 3 months
Secondary outcome [1] 279451 0
Time to achieve cure measured by a bladder diary
Timepoint [1] 279451 0
Daily recordings of wet/dry days collected every 2 weeks for 3 months
Secondary outcome [2] 279466 0
Change in daytime wetting (compared to baseline)
Timepoint [2] 279466 0
Daily recordings of wet/dry days collected every 2 weeks for 3 months
Secondary outcome [3] 279467 0
Completeness of bladder emptying (compared to baseline)
Timepoint [3] 279467 0
End of treatment at 3 months using uroflow measurements.
Secondary outcome [4] 279468 0
Proportion relapsed by 6 months (to assess whether treatment success is sustained)
Timepoint [4] 279468 0
2 monthly recordings.
Secondary outcome [5] 279469 0
Satisfaction questionnaire incorporating the child and families satisfaction with the treatment protocol including their attitude to the watch, length of treatment, relapse and their overall satisfaction of treatment received
Timepoint [5] 279469 0
End of treatment (at 3 months)
Secondary outcome [6] 279470 0
Quality of life
Timepoint [6] 279470 0
Measured at baseline and end of treatment (at 3 months). Quality of life will be assessed using a validated questionnaire.

Eligibility
Key inclusion criteria
Children aged 5 to 13 years who have DUI at least twice per week (in the past 2 weeks) for which a timed voiding program is indicated
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with an organic cause for DUI including defects of central nervous system or underlying urological abnormality or where a timed voiding program is contraindicated

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
National Health and Medical Research Council clinical trials centre central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratify by age, gender and disease severity. Randomisation will be generated by minimisation method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Analysis by intention to treat
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/08/2011
Actual
10/10/2011
Date of last participant enrolment
Anticipated
31/12/2015
Actual
4/12/2016
Date of last data collection
Anticipated
Actual
13/09/2017
Sample size
Target
360
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269592 0
Charities/Societies/Foundations
Name [1] 269592 0
Financial Markets foundation for children
Country [1] 269592 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmad
Address
Locked bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 266622 0
None
Name [1] 266622 0
Address [1] 266622 0
Country [1] 266622 0
Other collaborator category [1] 252169 0
University
Name [1] 252169 0
The University of Sydney
Address [1] 252169 0
Sydney NSW 2006
Country [1] 252169 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269543 0
The Children's Hospital at Westmead ethics committee
Ethics committee address [1] 269543 0
Locked bag 4001
Westmead NSW 2145
Ethics committee country [1] 269543 0
Australia
Date submitted for ethics approval [1] 269543 0
Approval date [1] 269543 0
10/06/2011
Ethics approval number [1] 269543 0
11/CHW/12

Summary
Brief summary
Daytime urinary incontinence is very common in children and impacts on self-esteem, socialisation opportunities and quality of life, with the potential to lead to adult urinary incontinence with associated psychosocial comorbidities. The estimated annual cost for urinary incontinence in Australian children aged 5-15 is at least $116.1 million (extrapolating from 2001 adult data of $387 per person in 10% children aged 5-15). Timed voiding is an effective, non-pharmacological treatment for treating DUI in adults, but is less effective in children, possibly due to poor compliance. The use of a personal alarm watch may enhance the effectiveness of timed voiding in children.
A randomised controlled trial is the best research method to definitively answer the question of whether timed voiding aided by an alarm watch is superior to timed voiding alone. If found to be successful, incorporating a personalised alarm watch to aid timed voiding will provide a simple, inexpensive but effective non-pharmacological treatment for managing daytime urinary incontinence in children. If the alarm watch does not improve timed voiding, this knowledge will reduce unnecessary financial costs for families.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32970 0
A/Prof Patrina Caldwell
Address 32970 0
Centre for Kidney Research The Children's Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
Country 32970 0
Australia
Phone 32970 0
+61 2 9845 3406
Fax 32970 0
+61 2 9845 1491
Email 32970 0
[email protected]
Contact person for public queries
Name 16217 0
Ms Ms Marianne Kerr
Address 16217 0
Centre for Kidney Research
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 16217 0
Australia
Phone 16217 0
+61 2 9845 1481
Fax 16217 0
+61 2 9845 1491
Email 16217 0
[email protected]
Contact person for scientific queries
Name 7145 0
Dr Dr Patrina Caldwell
Address 7145 0
Centre for Kidney Research
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 7145 0
Australia
Phone 7145 0
+61 2 9845 1462
Fax 7145 0
+61 2 9845 1491
Email 7145 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn Alarm Watch for Daytime Urinary Incontinence: A Randomized Controlled Trial.2022https://dx.doi.org/10.1542/peds.2021-053863
N.B. These documents automatically identified may not have been verified by the study sponsor.