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Trial registered on ANZCTR


Registration number
ACTRN12609000070235
Ethics application status
Approved
Date submitted
11/12/2008
Date registered
28/01/2009
Date last updated
12/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Nocturnal Enuresis Alarm Therapy (NEAT) Study
Scientific title
A randomised controlled trial comparing the proportion of patients with nocturnal enuresis cured at 4 months by the code game alarm or with the standard enuresis alarm
Secondary ID [1] 768 0
None
Universal Trial Number (UTN)
Trial acronym
NEAT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nocturnal enuresis 4123 0
Condition category
Condition code
Renal and Urogenital 4318 4318 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel code game enuresis alarm which needs a code word for sensing wettness. The sensor is secured in a pad and can be worn inside the child's underpants. This alarm will emit an audio signal to wake the child. The participant will be using this alarm until cure or for a maximum of 4 months.
Intervention code [1] 3832 0
Treatment: Devices
Comparator / control treatment
Commonly used standard enuresis alarm which will will emit an audio signal when wettness is detected to wake the child. The participant will be using this alarm until cure or for a maximum of 4 months.
Control group
Active

Outcomes
Primary outcome [1] 5208 0
Proportion of patients cured at 4 months measured by a bladder diary
Timepoint [1] 5208 0
Daily recordings of wet/dry nights collected every 2 weeks for 4 months
Secondary outcome [1] 8761 0
Time to achieve cure measured by bladder diary
Timepoint [1] 8761 0
Daily recordings of wet/dry nights collected every 2 weeks for 4 months
Secondary outcome [2] 8762 0
Proportion of patients relapsed by 12 months. Relapse is defined as greater than 2 nights of wetting/fortnight after achieving cure.
Timepoint [2] 8762 0
12 months
Secondary outcome [3] 8763 0
Response to alarm stimulus will be measured by a bladder diary
Timepoint [3] 8763 0
Daily recordings of wet/dry nights, waking to void and time to achieve cure will be collected every 2 weeks for 4 months
Secondary outcome [4] 8764 0
Adverse outcomes (disturbed sleep) will be assessed daily by a bladder diary kept by the participants.
Timepoint [4] 8764 0
Daily recordings of any adverse outcomes collected every 2 weeks for 4 months
Secondary outcome [5] 8765 0
Overall response to treatment (cure rate) in both arms will be measured by a bladder diary
Timepoint [5] 8765 0
Daily recordings of wet/dry nights, waking to void, time to achieve cure and any relapse will be collected every 2 weeks for 12 months

Eligibility
Key inclusion criteria
Children >6 years with nocturnal enuresis for at least 3 nights per week for which enuresis alarm therapy is indicated
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with organic cause for nocturnal enuresis, defects of central nervous system or significant underlying urological abnormalities or those where alarm therapy 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 centre, age and gender. Randomised sequence will be generated by permuted block randomisation or dynamic random allocation methods such as minimisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
7/05/2009
Date of last participant enrolment
Anticipated
Actual
29/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4283 0
Government body
Name [1] 4283 0
National Health and Medical Research Council -Project grant
Country [1] 4283 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 3856 0
Hospital
Name [1] 3856 0
The Children's Hospital at Westmead
Address [1] 3856 0
Locked Bag 4001
Westmead NSW 2145
Country [1] 3856 0
Australia
Secondary sponsor category [2] 3857 0
University
Name [2] 3857 0
The University of Sydney
Address [2] 3857 0
Sydney NSW 2000
Country [2] 3857 0
Australia
Other collaborator category [1] 509 0
Individual
Name [1] 509 0
Mr Geoffrey Wickham
Address [1] 509 0
115 Jollys Hill Road
Smythes Creek VIC 3352
Country [1] 509 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6336 0
The Children's Hospital at Westmead Ethics Committee
Ethics committee address [1] 6336 0
Ethics committee country [1] 6336 0
Australia
Date submitted for ethics approval [1] 6336 0
19/07/2007
Approval date [1] 6336 0
22/08/2008
Ethics approval number [1] 6336 0
2007/063

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35036 0
Dr Patrina Caldwell
Address 35036 0
The Childrens Hospital at Westmead
Locked Bag 4001
WESTMEAD NSW 2145
Country 35036 0
Australia
Phone 35036 0
+61 2 9845 3406
Fax 35036 0
+61 2 9845 1491
Email 35036 0
[email protected]
Contact person for public queries
Name 12383 0
Sana Hamilton
Address 12383 0
Centre for Kidney Research
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 12383 0
Australia
Phone 12383 0
+61 2 9845 1471
Fax 12383 0
+61 2 9845 1491
Email 12383 0
[email protected]
Contact person for scientific queries
Name 3311 0
Patrina Caldwell
Address 3311 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 3311 0
Australia
Phone 3311 0
+61 2 9845 1462
Fax 3311 0
+61 2 9845 1491
Email 3311 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
EmbaseA randomised controlled trial of a code-word enuresis alarm.2016https://dx.doi.org/10.1136/archdischild-2015-308564
N.B. These documents automatically identified may not have been verified by the study sponsor.