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Trial registered on ANZCTR


Registration number
ACTRN12618000464268
Ethics application status
Approved
Date submitted
13/03/2018
Date registered
29/03/2018
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Date results information initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Abdominal Functional Electrical Stimulation to improve bowel and bladder function in Multiple Sclerosis
Scientific title
Abdominal Functional Electrical Stimulation to improve bowel and bladder function in Multiple Sclerosis
Secondary ID [1] 294290 0
None
Universal Trial Number (UTN)
U1111-1210-8681
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 306986 0
Functional Constipation 306987 0
Bladder incontinence 306988 0
Condition category
Condition code
Neurological 306082 306082 0 0
Multiple sclerosis
Renal and Urogenital 306338 306338 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 306339 306339 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
Abdominal functional electrical stimulation (Abdominal FES) is the application of a train of electrical pulses to the abdominal muscles, causing them to contract. Abdominal FES will be applied to the rectus abdominis and external oblique muscles for one hour per day (2 x 30 minutes, once in am and once in pm), five days per week, for six weeks. Researchers from Neuroscience Research Australia will visit the participant’s home and demonstrate how to apply this risk and complication free intervention, with participants applying the intervention at home for the remainder of their participation (compliance monitored via daily training diary). Stimulation will be applied bilaterally using four pairs of surface electrodes (33 mm x 53 mm, Axelgaard, USA). Current will be adjusted to achieve a visible contraction of the abdominal muscles without discomfort (likely to be 40-50 mA) at 40 Hz and a pulsewidth of 300 µs. Stimulation will be applied using a commercially available FES device (Empi Continuum, EMPI Inc, USA), with devices supplied to all participants.
Intervention code [1] 300589 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305119 0
Whole gut transit time, measured using the SmartPill motility system.
Timepoint [1] 305119 0
First day and last day of enrolment (on the day following the last day of the 6 week intervention)
Primary outcome [2] 305153 0
Colonic transit time, measured using Smartpill system
Timepoint [2] 305153 0
First and last day of enrolment (on the day following the last day of the 6 week intervention)
Secondary outcome [1] 344242 0
Patient Assessment of Constipation, assessed using patient assessment of constipation Quality of Life questionnaire
Timepoint [1] 344242 0
First and last day of enrolment (on the day following the last day of the 6 week intervention)
Secondary outcome [2] 344244 0
Incontience related quality of life, assessed using Incontinence Quality of Life questionnaire
Timepoint [2] 344244 0
First and last day of enrolment (on the day following the last day of the 6 week intervention)
Secondary outcome [3] 344931 0
Laxative use, reported using patient diary
Timepoint [3] 344931 0
At the end of each day of participation
Secondary outcome [4] 344932 0
frequency of defecation, reported using patient diary
Timepoint [4] 344932 0
At the end of each day of participation
Secondary outcome [5] 344933 0
Nocturia, reported using patient diary
Timepoint [5] 344933 0
At the end of each day of participation

Eligibility
Key inclusion criteria
Adults with diagnosed MS and an Expanded Disability Status Scale score of 3 to 8, who are able to eat and drink normally, fulfil the Rome III criteria for functional constipation, and constipated for at least three months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current urinary tract infection, pregnancy, history of irritable bowel syndrome, organic bowel obstruction or other bowel disease, physical obstacles that prevent Abdominal FES (e.g. abdominal trauma, pacemaker), no response to Abdominal FES (e.g. lower motor neuron impairment), taking medication designed to alter bowel or bladder function.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size
A case study of four patients with MS reported that Abdominal FES improved whole gut transit time with an effect size of 1.42. The small sample size is likely to have led to an overestimation of effect size. We believe we can conservatively detect an effect size of 0.71. As such, 24 participants are required (Wilcoxon signed rank, a=0.05, power=0.9).

Statistical Analysis
Based on the outcome of a normality test, a paired t-test or Wilcoxon signed rank test will be used to test for a significant difference in all outcome measures after the application of six weeks of Abdominal FES.

Recruitment
Recruitment status
Completed
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] 10361 0
Multiple Sclerosis Ltd (MS Ltd) - Studdy MS Centre - Lidcombe
Recruitment postcode(s) [1] 22032 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 298936 0
Government body
Name [1] 298936 0
National Health and Medical Research Council (NHMRC) Fellowship Funds
Address [1] 298936 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra
ACT 2601
Country [1] 298936 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 298148 0
None
Name [1] 298148 0
Address [1] 298148 0
Country [1] 298148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299871 0
University of New South Wales HREC Executive
Ethics committee address [1] 299871 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 299871 0
Australia
Date submitted for ethics approval [1] 299871 0
Approval date [1] 299871 0
08/03/2018
Ethics approval number [1] 299871 0
HC180005

Summary
Brief summary
Bowel and bladder problems, mainly in the form of constipation and urinary incontinence, affect more than half of people with Multiple Sclerosis (MS). These problems have traditionally been managed using a combination of manual and pharmacological interventions. However, such solutions are usually only partially effective. Therefore, a non-invasive method of improving bowel and bladder function for people with MS is urgently needed.

The abdominal muscles play a major role during defecation and urination. Surface electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (Abdominal FES), has been shown to improve bowel function after spinal cord injury, with a case study suggesting this technique may also improve bowel function in MS. There is also limited evidence that Abdominal FES can improve bladder control. Therefore, we propose the first significant study to investigate the effectiveness of Abdominal FES to improve the bowel and bladder function of people with MS.

Hypothesis: Abdominal FES can improve bowel and bladder function for people with MS.

Individual aims of this project are to assess the effect of Abdominal FES on:
1) whole gut and colonic transit time
2) constipation and laxative use
3) incontinence related quality of life
4) frequency of defecation and nocturia
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81826 0
Dr Euan McCaughey
Address 81826 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 81826 0
Australia
Phone 81826 0
+61 2 9399 1827
Fax 81826 0
Email 81826 0
e.mccaughey@neura.edu.au
Contact person for public queries
Name 81827 0
Dr Euan McCaughey
Address 81827 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 81827 0
Australia
Phone 81827 0
+61 2 9399 1827
Fax 81827 0
Email 81827 0
e.mccaughey@neura.edu.au
Contact person for scientific queries
Name 81828 0
Dr Euan McCaughey
Address 81828 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 81828 0
Australia
Phone 81828 0
+61 2 9399 1827
Fax 81828 0
Email 81828 0
e.mccaughey@neura.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All study data
When will data be available (start and end dates)?
Upon publication, no end date determined
Available to whom?
All
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
unrestricted access via publication
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary