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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

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]

None

Universal Trial Number (UTN)

U1111-1210-8681

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple Sclerosis

Functional Constipation

Bladder incontinence

Condition category

Condition code

Neurological

Multiple sclerosis

Renal and Urogenital

Other renal and urogenital disorders

Oral and Gastrointestinal

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Whole gut transit time, measured using the SmartPill motility system.

Timepoint [1]

First day and last day of enrolment (on the day following the last day of the 6 week intervention)

Primary outcome [2]

Colonic transit time, measured using Smartpill system

Timepoint [2]

First and last day of enrolment (on the day following the last day of the 6 week intervention)

Secondary outcome [1]

Patient Assessment of Constipation, assessed using patient assessment of constipation Quality of Life questionnaire

Timepoint [1]

First and last day of enrolment (on the day following the last day of the 6 week intervention)

Secondary outcome [2]

Incontience related quality of life, assessed using Incontinence Quality of Life questionnaire

Timepoint [2]

First and last day of enrolment (on the day following the last day of the 6 week intervention)

Secondary outcome [3]

Laxative use, reported using patient diary

Timepoint [3]

At the end of each day of participation

Secondary outcome [4]

frequency of defecation, reported using patient diary

Timepoint [4]

At the end of each day of participation

Secondary outcome [5]

Nocturia, reported using patient diary

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

2/04/2018

Actual

16/04/2018

Date of last participant enrolment

Anticipated

Actual

8/03/2019

Date of last data collection

Anticipated

Actual

19/04/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Multiple Sclerosis Ltd (MS Ltd) - Studdy MS Centre - Lidcombe

Recruitment postcode(s) [1]

2141 - Lidcombe

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Fellowship Funds

Address [1]

National Health and Medical Research Council (NHMRC) GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Neuroscience Research Australia

Address

139 Barker Street
Randwick
NSW 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales HREC Executive

Ethics committee address [1]

UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/03/2018

Ethics approval number [1]

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

Dr Euan McCaughey

Address

Neuroscience Research Australia 139 Barker Street Randwick NSW 2031

Country

Australia

Phone

+61 2 9399 1827

Fax

[email protected]

Contact person for public queries

Name

Euan McCaughey

Address

Neuroscience Research Australia 139 Barker Street Randwick NSW 2031

Country

Australia

Phone

+61 2 9399 1827

Fax

[email protected]

Contact person for scientific queries

Name

Euan McCaughey

Address

Neuroscience Research Australia 139 Barker Street Randwick NSW 2031

Country

Australia

Phone

+61 2 9399 1827

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• All

Conditions for requesting access:
• -

What individual participant data might be shared?

• All study data

What types of analyses could be done with individual participant data?

• IPD meta-analysis

When can requests for individual participant data be made (start and end dates)?

From:
Upon publication, no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• unrestricted access via publication

Are there extra considerations when requesting access to individual participant data?

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

Source	Title	Year of Publication	DOI
Embase	The effect of abdominal functional electrical stimulation on bowel function in multiple sclerosis: a cohort study.	2020	https://dx.doi.org/10.1177/2055217320941530

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically