Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000938303
Ethics application status
Approved
Date submitted
14/06/2017
Date registered
28/06/2017
Date last updated
11/02/2021
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A cohort study of the effects of transcutaneous electrical nerve stimulation (TENS) on psychosocial and incontinence outcomes in children with overactive bladder syndrome
Scientific title
A cohort study of the effects of transcutaneous electrical nerve stimulation (TENS) on psychosocial and incontinence outcomes in children with overactive bladder syndrome
Secondary ID [1] 292184 0
None
Universal Trial Number (UTN)
Not applicable
Trial acronym
Not applicable
Linked study record
.

Health condition
Health condition(s) or problem(s) studied:
Overactive bladder syndrome in children 303656 0
Condition category
Condition code
Renal and Urogenital 303042 303042 0 0
Other renal and urogenital disorders
Mental Health 303043 303043 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TENS is based on the gate control theory of abolishing the local micturition reflex arc. The sticky electrodes are applied on the lower back, on the bladder dermatome S2, S3 and S4. The child is encouraged to wear the TENS for 1 hour every day for three months. The TENS is set at a frequency 10 Hz with the current density set as has as tolerated by the child. Children attending the urinary incontinence clinics at The Children's Hospital at Westmead and John Hunter Children’s Hospital in Newcastle, who are diagnosed with overactive bladder who require additional treatment for their overactive bladder after at least one month of urotherapy will be invited to participate in the study. Children are referred by their general practitioners or specialists to the clinics. Parents will be informed that parasacral TENS is an alternative to the pharmacological treatment with anticholinergics. Those wishing to participate in the study and have provided informed consent will be provided with a TENS machine for three months.
Children and their parents will be instructed on how to use the TENS, which will be used in their homes at times convenient to them. the child will be asked to wear the TENS (set at 10 Hz) for 60 minutes per day for 3 months. The study coordinator will contact study participants every 4 weeks to provide additional support and to evaluate their progress. Participants will be asked to complete 3 baseline questionnaires at enrolment and after 3 months of TENS use.
As this study forms part of an international collaboration, data from the Australian sites will be also be compared with data from Germany and Brazil.
Intervention code [1] 298338 0
Treatment: Devices
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302416 0
quality of life (pinQ score)
Timepoint [1] 302416 0
pre and post treatment
Primary outcome [2] 302490 0
behaviour (SDQ score)
Timepoint [2] 302490 0
pre and post treatment
Secondary outcome [1] 335908 0
Change in ICIQ-CLUTS score
Timepoint [1] 335908 0
pre and post treatment
Secondary outcome [2] 336175 0
Change in mean voiding frequency
Timepoint [2] 336175 0
by comparing 48-h bladder diary data pre and post treatment
Secondary outcome [3] 336176 0
Change in maximum voided volume
Timepoint [3] 336176 0
by comparing 48-h bladder diary pre and post treatment
Secondary outcome [4] 336178 0
Change in post void residual urine
Timepoint [4] 336178 0
by comparing bladder scan pre and post treatment

Eligibility
Key inclusion criteria
All children who present to the outpatient incontinence clinics at the Children’s Hospital at Westmead and John Hunter Children’s Hospital with overactive bladder who have had at least one month of urotherapy, for which treatment with TENS is indicated, where parents chose to use TENS instead of anticholinergic medications as first line therapy
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have previously used or are currently using anticholinergics for overactive bladder syndrome. Also patients with concomitant faecal incontinence.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Before after study - comparison with baseline
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size 30 at both CHW and JHCH: A sample of 30 patients will have 80% power at 5% one-sided significance to detect a within-patient improvement of 0.5 standard deviations in the continuous outcomes SDQ and PinQ scores after 3 months of treatment with TENS using a one-sample t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
16/03/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
11/03/2020
Date of last data collection
Anticipated
30/03/2020
Actual
14/07/2020
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8338 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 8339 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 16408 0
2145 - Westmead
Recruitment postcode(s) [2] 16409 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 296721 0
Hospital
Name [1] 296721 0
The Children's Hospital at Westmead
Country [1] 296721 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Patrina Caldwell
Address
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 295688 0
None
Name [1] 295688 0
Address [1] 295688 0
Country [1] 295688 0
Other collaborator category [1] 279601 0
Individual
Name [1] 279601 0
Dr Aniruddh Deshpande
Address [1] 279601 0
John Hunter Hospital Lookout Rd New Lambton Heights NSW 2305
Country [1] 279601 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297948 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 297948 0
Ethics committee country [1] 297948 0
Australia
Date submitted for ethics approval [1] 297948 0
01/08/2017
Approval date [1] 297948 0
12/12/2017
Ethics approval number [1] 297948 0

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

Contacts
Principal investigator
Name 75550 0
A/Prof Patrina Caldwell
Address 75550 0
Centre for Kidney Research The Children's Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
Country 75550 0
Australia
Phone 75550 0
+612 9845 3406
Fax 75550 0
+612 9845 1491
Email 75550 0
[email protected]
Contact person for public queries
Name 75551 0
Patrina Caldwell
Address 75551 0
Centre for Kidney Research The Children's Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
Country 75551 0
Australia
Phone 75551 0
+612 9845 3406
Fax 75551 0
+612 9845 1491
Email 75551 0
[email protected]
Contact person for scientific queries
Name 75552 0
Patrina Caldwell
Address 75552 0
Centre for Kidney Research The Children's Hospital at Westmead Locked Bag 4001 Westmead NSW 2145
Country 75552 0
Australia
Phone 75552 0
+612 9845 3406
Fax 75552 0
+612 9845 1491
Email 75552 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2263Informed consent form    Study-related document.docx
2264Study protocol    we are happy for the protocol to be publicly avail... [More Details] Study-related document.docx
2265Ethical approval    Study-related document.pdf



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.