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Trial registered on ANZCTR


Registration number
ACTRN12614001011673
Ethics application status
Approved
Date submitted
10/09/2014
Date registered
19/09/2014
Date last updated
19/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Electrical therapy for faecal incontinence in children with spina bifida
Scientific title
Transcutaneous electrical stimulation as an alternative therapy for faecal incontinence in children with spina bifida
Secondary ID [1] 285148 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence 292738 0
Spina bifida 293084 0
Condition category
Condition code
Neurological 293031 293031 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 293358 293358 0 0
Other human genetics and inherited disorders
Oral and Gastrointestinal 293359 293359 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The transcutaneous electrical stimulation (TES) machine is a small device (approximately 20 cm x 30 cm), connected to 240V power source. It has two independent channels of current. We use electrodes that are small sticky pads of 4 cm x 4 cm (pure silicon). The device delivers an interferential current with a carrier frequency of 4 Hz, a beat frequency sweep covering 80 to 160 Hz, with an adjustable intensity less than 33 milliA. Individual pulses have duration of 250 micros (constant alternating current).
Two pairs of electrodes are placed on the front and on the back of the inferior abdomen. Stimulation will be delivered daily for 1 hour, either mornings or evenings, for 2 months, at home, by the participant themselves or their carer.
Patients will be in contact by phone each week and asked if they have used the TES each day and for how long. TES use will be recorded on the daily bowel diary.
Intervention code [1] 289998 0
Treatment: Devices
Comparator / control treatment
Participants will provide their own control data.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292893 0
Severity of faecal incontinence (based on the bowel diaries). The bowel diaries will record frequency of bowel movements, time spent for defecation, need for help for evacuation (digital stimulation, laxatives, enemas), feeling of completeness of evacuation, associated pain, frequency of faecal incontinence, incontinence for solid or liquid stool, incontinence for gas, need to wear a pad or a plug. It is a composite primary outcome: this will allow us to obtain a score of faecal incontinence (St-Marks faecal incontinence score).
Timepoint [1] 292893 0
Daily diaries will be completed by the participant during a two times two-week period, during the 2 months of baseline measurements and then during the 2 months of the intervention (stimulation), .
Secondary outcome [1] 309880 0
Quality of life (assessed by the FICQOL questionnaire)

Timepoint [1] 309880 0
Before intervention (baseline) and on completion of the 2-month intervention period
Secondary outcome [2] 309881 0
Colonic transit time (evaluation by radiopaque markers)
Timepoint [2] 309881 0
Before intervention and on completion of the 2-month intervention period

Eligibility
Key inclusion criteria
*Presenting with spina bifida aperta or open neural tube defect (i.e. myelomeningocele, meningocele or myeloschisis);
*Aged between 8 and 18 years old at the time of screening;
*Faecal incontinence reported for the last 6 months,
*Failed management of faecal incontinence with retrograde continence enema,
*Ability to answer questionnaires and complete the diary, with parental assistance if necessary.
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Has a heart pacemaker or a cochlear implant;
*Has abnormal abdominal sensation
*Presents symptoms or signs of bowel obstruction;
*Has cancer;
*Is pregnant (pregnancy test planned before TES);
*Has had a previous diagnosis of a metabolic or hormonal disorder; and,
*Non English speaking.

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)
Faecal incontinence in children with spina bifida is currently treated by retrograde continence enema. Transcutaneous electrical therapy will be proposed as an alternative therapy to children with spina bifida aged 8-18 who have failed retrograde continence enema treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This phase II study will provide data about the distribution of the incontinence frequency in the population of children with spina bifida who failed treatment with retrograde continence enema. The population is foreseen to be heterogeneous.
We will compare the severity of faecal incontinence and the quality of life before and at the end of 2 months of transcutaneous electrical stimulation. After this study, the range of confidence intervals could be estimated.

Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment hospital [1] 2829 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 2830 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 8519 0
3052 - Parkville
Recruitment postcode(s) [2] 8520 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 289760 0
Hospital
Name [1] 289760 0
Urology department,
The Royal Children's Hospital
Address [1] 289760 0
50 Flemington Road
Parkville Victoria 3052 Australia
Country [1] 289760 0
Australia
Funding source category [2] 289761 0
Other
Name [2] 289761 0
Surgical Research
Murdoch Childrens Research Institute
Address [2] 289761 0
50 Flemington Road
Parkville Victoria 3052
Country [2] 289761 0
Australia
Funding source category [3] 289762 0
Hospital
Name [3] 289762 0
Departement de medico-chirurgical de pediatrie
Centre Hospitalier Universitaire Vaudois
Address [3] 289762 0
21 Rue du Bugnon
1011 Lausanne
Country [3] 289762 0
Switzerland
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
50 Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 288451 0
None
Name [1] 288451 0
Address [1] 288451 0
Country [1] 288451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291484 0
The Royal Children's Hospital HREC
Ethics committee address [1] 291484 0
50 Flemington Road
Parkville Victoria 3052
Ethics committee country [1] 291484 0
Australia
Date submitted for ethics approval [1] 291484 0
Approval date [1] 291484 0
01/08/2014
Ethics approval number [1] 291484 0
34056A

Summary
Brief summary
The aim of the study is to determine if transcutaneous electrical stimulation can reduce the severity of persistent faecal incontinence in a group of children with spina bifida previously unsuccessfully treated with retrograde continence enema.
Faecal incontinence in children with spina bifida is currently treated by retrograde continence enema. Transcutaneous electrical therapy will be proposed as an alternative therapy to children with spina bifida aged 8-18 who have failed retrograde continence enema treatment.
We have not tested transcutaneous electrical stimulation on children with spina bifida. There has been one study using transcutaneous electrical stimulation to treat faecal incontinence in children with spina bifida but there were no quantitative outcome measures that could be used to predict the number of patients needed in a randomized control trial.
A baseline period will be followed with a therapy (stimulation) period.
Outcomes measurements will be compared before and after stimulation. Outcomes are severity of faecal incontinence, quality of life and colonic transit time.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50630 0
A/Prof Yves Heloury
Address 50630 0
Urology department,
The Royal Children's Hospital
50 Flemington Road
Parkville Victoria 3052
Country 50630 0
Australia
Phone 50630 0
+61393455400
Fax 50630 0
Email 50630 0
Yves.Heloury@rch.org.au
Contact person for public queries
Name 50631 0
Dr Lefteris Stathopoulos
Address 50631 0
Surgical Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052
Country 50631 0
Australia
Phone 50631 0
+61399366757
Fax 50631 0
Email 50631 0
lefteris.stathopoulo@mcri.edu.au
Contact person for scientific queries
Name 50632 0
Dr Lefteris Stathopoulos
Address 50632 0
Surgical Research
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria 3052
Country 50632 0
Australia
Phone 50632 0
+61399366757
Fax 50632 0
Email 50632 0
lefteris.stathopoulo@mcri.edu.au

No data has been provided for results reporting
Summary results
Not applicable