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Trial registered on ANZCTR


Registration number
ACTRN12617000938303
Ethics application status
Approved
Date submitted
14/06/2017
Date registered
28/06/2017
Date last updated
11/06/2019
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
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 296721 0
Hawkesbury Rd Westmead NSW 2145
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
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
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
Transcutaneous electrical nerve stimulation (TENS) is an effective treatment method for overactive bladder and urge incontinence in children (de Gennaro et al., 2011; Barroso et al., 2011). The aim of the study is to analyse the effects of TENS on psychosocial outcomes,quality of life and lower urinary tract symptoms (LUTS) for treating overactive bladder in children by comparing changes in the strengths and difficulties questionnaire (SDQ) scores, the PinQ (paediatric incontinence quality of life) scores and lower urinary tract symptom scores (ICIQ-CLUTS – International Consultation on Incontinence Questionnaire – Pediatric Lower Urinary Tract Symptoms) before and after treatment with TENS for 3 months.
The following hypotheses shall be examined:
1. Is there an improvement in psychological symptoms after three months of treatment with TENS?
2. Is there an improvement in quality of life scores after three months of treatment with TENS?
3. Is there a reduction in lower urinary tract symptoms after three months of treatment with TENS?
Trial website
none
Trial related presentations / publications
none yet
Public notes
This study is part of an international collaboration, Data from the Australian sites will be also be compared with data from Germany and Brazil.

Germany and Brazil have not registered the study.

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
patrina.caldwell@health.nsw.gov.au
Contact person for public queries
Name 75551 0
A/Prof 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
patrina.caldwell@health.nsw.gov.au
Contact person for scientific queries
Name 75552 0
A/Prof 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
patrina.caldwell@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2263 0
Informed consent form
Citation [1] 2263 0
Link [1] 2263 0
Email [1] 2263 0
Other [1] 2263 0
Type [2] 2264 0
Study protocol
Citation [2] 2264 0
Link [2] 2264 0
Email [2] 2264 0
Other [2] 2264 0
we are happy for the protocol to be publicly available.
Type [3] 2265 0
Ethical approval
Citation [3] 2265 0
Link [3] 2265 0
Email [3] 2265 0
Other [3] 2265 0
Summary results
No Results