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Trial registered on ANZCTR


Registration number
ACTRN12619000354189
Ethics application status
Approved
Date submitted
26/02/2019
Date registered
6/03/2019
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between the effectiveness of the body-worn alarm system and a bell-and-pad alarm system for the management of bed wetting in children.
Scientific title
Validity of a body-worn alarm system for the effective management of enuresis in children: A study in Western Victoria
Secondary ID [1] 297437 0
WA-733871_Peck
Universal Trial Number (UTN)
U1111-1228-7997
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Enuresis 311618 0
Condition category
Condition code
Renal and Urogenital 310243 310243 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once consented/recruited, each child and family is randomly allocated to an intervention group.
Body-Worn Group (Intervention/Experimental Group)
The body-worn group will be provided with the device and instructions on its specific use. The body-worn device includes a sensor that connects to the underwear of the child which is also attached to an alarm unit that will sound when the sensor becomes wet.
The alarm device is 53x50x17 mm in size and has a clip that attaches to the child underwear. A sensor 25x20x3 mm is placed within the underwear to make contact with the urine once the child begins to wet. The sensor has 8 alarm tones that sound when the device sensor is wet.
The device is encouraged to be used every night for a period of uptown 16 weeks or at the point at which the child is dry for 14 consecutive dry nights.
Participants are asked to maintain a bedwetting diary. Parents of the child will be asked to complete the diary to the best of their ability on a daily basis.
The intervention takes place in the child's normal place of sleep. An advantage of the body-worn device is the ability to take the alarm to different sites if required i.e. holidays, family homes etc.
Intervention code [1] 313696 0
Treatment: Devices
Comparator / control treatment
Once consented/recruited, each child and family is randomly allocated to an intervention group.
Bell-Pad Group (Traditional/Control Group)
The bell-pad group will be provided with the device and instructions on its specific use. The bell-pad device includes a hard pad - approx. A1 paper size - that is situated under the sheet of the bed inline with the child's pelvis. The pad is attached to a larger alarm unit that will sound when the pad becomes wet.
Control group
Active

Outcomes
Primary outcome [1] 319131 0
The rates of success attained using the two different types of enuresis alarm device will be compared using a non- inferiority test of proportions. The data will be collected from the participant diary.
Timepoint [1] 319131 0
At a time point where the child has achieved either: 14 consecutive dry nights or at the completion 16 weeks therapy, or at the point of withdrawing from the therapy.
Secondary outcome [1] 367064 0
The time to attain 14 consecutive nights dry for the two different types of enuresis alarm device. The data will be collected from the participant diary.
Timepoint [1] 367064 0
At a time point where the child has achieved either: 14 consecutive dry nights or at the completion 16 weeks therapy, or at the point of withdrawing from the therapy.
Secondary outcome [2] 367642 0
Changes in Quality of life using the Quality of Life Questionnaire (CHU-9D) across the study period for those children recruited to the study
Timepoint [2] 367642 0
At the timepoint of recruitment to the study children will complete the Quality of Life Questionnaire (CHU-9D).
At the achievement of 14 resecutive dry nights, or the end of 16 week period the child will complete a Quality of Life Questionnaire (CHU-9D)
Secondary outcome [3] 367643 0
The experience of children who have undergone treatment for nocturnal enuresis. Following consent/assent children with enuresis will participate in one-one interview with the Principal Researcher that is anticipated to be a maximum of 30 minutes in duration.
Timepoint [3] 367643 0
At a time point where the child achieved 14 consecutive dry nights, or at the end of a 16 week period of therapy the child will be invited to participate in an interview.
Secondary outcome [4] 367644 0
The experience of parents who have a child undergoing treatment for nocturnal enuresis. Consenting parents of the child with enuresis Children will participate in one-one interview with the Principal Researcher that is anticipated to be a maximum of 30 minutes in duration.
Timepoint [4] 367644 0
At a time point where the child achieved 14 consecutive dry nights, or at the end of a 16 week period of therapy the child will be invited to participate in an interview.

Eligibility
Key inclusion criteria
Developmentally healthy children (male and female) who are between the ages of 6 and 15 years and 11 months old and who have presented to the Grampians Regional Continence Service with bedwetting and have subsequently been diagnosed with enuresis.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children younger than 6 or older than 16 years of age
Children who have been identified as having significant medical history (e.g. spina bifida or cerebral palsy).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The the procedure for sequence generation at each clinical site involved in this study.

At each site the number of existing bell and pad devices in circulation will vary. For ease of understanding lets assume that the number of bell and pad devices at any given site is represented by x.

At the start of the project, the existing bell and pad alarm units (x) will already be in use, and an equivalent amount of new body-worn alarm units will be ready for use. For example, if a clinical site has 20 bell and pad devices, then an equivalent 20 body-worn devices will be introduced for randomisation.

Initially, any children already on the waiting list for enuresis alarm therapy will be contacted in sequence and offered access to a body-worn alarm unit. If there are 20 body-worn devices introduced, then the first 20 children who accept the use of the body-worn device will not be a part of the study.

Any bell and pad units that are returned during the process of the previous step will be distributed in the same manner. The study will commence only when all the allocated body-worn units are in use and as of the first unit being returned for redistribution.

As each alarm unit is returned and becomes available, then the next eligible and consenting child/parent will be provided with the unit.

Randomisation is designed to ensure that every participant has an equal probability of being allocated to a particular type of alarm unit. Under this strategy, the allocation of the type of alarm to a particular participant is randomised, not by an explicit algorithmically-based randomisation schedule, but rather by the probabilistic nature of the arrival processes of both eligible participants and returned alarm units.

However, if there is a difference in the efficacy of the two types of alarm, then one type of alarm may become available more frequently than the other type, leading to unequal probabilities of allocation to the two types. Notwithstanding this, the same unequal probabilities will apply to all participants.

This strategy would maximise the sample size achieved over a particular study duration, because no potential participants will be excluded through lack of availability of a specified type of alarm. The trade-off is the likelihood of unequal sample sizes for the two types of alarm.

While this imbalance would not invalidate the comparative analysis, it would also be possible to test the sensitivity of the results to the sample size imbalance by carrying out an ancillary analysis using a sub-sample from the larger sample, randomly selected post hoc, of equal size to the smaller sample. Of course the overall sample size would be reduced in this analysis, which could complicate the comparison of the results of the two analyses. Such post hoc exclusion would in many situations be regarded as unethical (wasting the time of participants whose data is not analysed), but this does not apply in the real-world clinical context, where the participants potentially obtain health benefits by participating, are not subjected to any risks and are not required to do anything beyond routine reporting for clinical purposes.

At the start of the project children who are eligible for enuresis alarm therapy (including those on the waiting list database) will be contacted and offered access to the study. Each child contacted will be provided with the next available enuresis alarm, whether it be the body-worn or the bell and pad device. It is anticipated that this will in effect provide each participant with the same probability of being allocated either of the two types of enuresis alarm devices. It is noted that if there is a difference in the efficacy of the two types of alarm device used, then the type of device which results in more rapid ‘success’ will become available more frequently than the other type, leading to unequal probabilities of allocation to the two types. However, the same unequal probabilities will apply to all participants.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The procedures of statistical analysis are specific to both the Primary and Secondary Outcome Measures as follows:
Primary Outcome Measure -The rates of success attained using the two different types of enuresis alarm device will be compared using a non- inferiority test of proportions. Secondary Outcome Measure - The time to attain dryness using the two different types of enuresis alarm device will be compared using an independent samples t-test and a survival analysis by Cox regression modelling.

Supplementary analyses - More complex variants of the analysis of both outcome measures may be conducted, including ancillary factors and covariates such as gender and age.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
15/07/2020
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13265 0
Ballarat Health Services - Queen Elizabeth Centre - Ballarat
Recruitment hospital [2] 13266 0
East Grampians Health Service - Ararat - Ararat
Recruitment hospital [3] 13267 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [4] 13268 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 25830 0
3350 - Ballarat
Recruitment postcode(s) [2] 25831 0
3377 - Ararat
Recruitment postcode(s) [3] 25832 0
3400 - Horsham
Recruitment postcode(s) [4] 25833 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 302009 0
Other Collaborative groups
Name [1] 302009 0
Western Allaince Health Research LTD
Country [1] 302009 0
Australia
Primary sponsor type
University
Name
Federation University Australia
Address
Federation University Australia
School of Nursing & Healthcare Professions
University Drive, Mount Helen,
PO Box 663, Ballarat, Victoria, 3353
Australia,
Country
Australia
Secondary sponsor category [1] 301791 0
Hospital
Name [1] 301791 0
Ballarat Health Services - Grampians Regional Continence Service
Address [1] 301791 0
102 Ascot St S, Ballarat Central VIC 3350
Country [1] 301791 0
Australia
Secondary sponsor category [2] 301917 0
Hospital
Name [2] 301917 0
East Grampians Healthcare - Continence Service
Address [2] 301917 0
5 Girdlestone Street, ARARAT 3377 VIC
Country [2] 301917 0
Australia
Secondary sponsor category [3] 301919 0
Hospital
Name [3] 301919 0
Barwon Health
Address [3] 301919 0
Bellarine Street, Geelong, Victoria, 3220
Country [3] 301919 0
Australia
Secondary sponsor category [4] 301920 0
Hospital
Name [4] 301920 0
Wimmera Healthcare Group
Address [4] 301920 0
83 Baillie St, Horsham VIC 3400
Country [4] 301920 0
Australia
Secondary sponsor category [5] 301921 0
University
Name [5] 301921 0
Deakin University (Geelong)
Address [5] 301921 0
1 Gheringhap St, Geelong VIC 3220
Country [5] 301921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302684 0
Barown Health Human Research Ethics Committee
Ethics committee address [1] 302684 0
Ethics committee country [1] 302684 0
Australia
Date submitted for ethics approval [1] 302684 0
14/03/2018
Approval date [1] 302684 0
16/05/2018
Ethics approval number [1] 302684 0
17/93

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

Contacts
Principal investigator
Name 91050 0
Dr Blake Peck
Address 91050 0
Federation University Australia
School of Nursing and Healthcare Professions
University Drive, Mount Helen
PO Box 663, Ballarat, Victoria, 3353,
Country 91050 0
Australia
Phone 91050 0
+61 3 5327 9097
Fax 91050 0
Email 91050 0
b.peck@federation.edu.au
Contact person for public queries
Name 91051 0
Blake Peck
Address 91051 0
Federation University Australia
School of Nursing and Healthcare Professions
University Drive, Mount Helen
PO Box 663, Ballarat, Victoria, 3353,
Country 91051 0
Australia
Phone 91051 0
+61 3 5327 9097
Fax 91051 0
Email 91051 0
b.peck@federation.edu.au
Contact person for scientific queries
Name 91052 0
Blake Peck
Address 91052 0
Federation University Australia
School of Nursing and Healthcare Professions
University Drive, Mount Helen
PO Box 663, Ballarat, Victoria, 3353,
Country 91052 0
Australia
Phone 91052 0
+61 3 5327 9097
Fax 91052 0
Email 91052 0
b.peck@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been approved by the authorising HREC.


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
No additional documents have been identified.