Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12621000386831
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
7/04/2021
Date last updated
14/10/2024
Date data sharing statement initially provided
7/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Abdominal Functional Electrical Stimulation On Bowel Function In Spinal Cord Injury
Scientific title
The Effect of Abdominal Functional Electrical Stimulation On Bowel Function In Adults with a Spinal Cord Injury: A prospective cohort trial
Secondary ID [1] 302986 0
None
Universal Trial Number (UTN)
U1111-1262-5380
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 320037 0
Tetraplegia 320038 0
Paralysis 320039 0
Condition category
Condition code
Neurological 317962 317962 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 317963 317963 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 317964 317964 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Colorectal, anal and pelvic floor complications are common in people with spinal cord injury (SCI). The abdominal muscles are one of the major muscle groups used during expiratory and expulsive manoeuvres such as defecation and coughing. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function. Furthermore, there is evidence that abdominal FES may also improve bowel function in people with SCI via increased intra-abdominal pressure. However, there is a lack of data from randomised, controlled trials to substantiate this evidence and there is no standard Abdominal FES protocol for improving bowel function.

34 people will be recruited to this prospective cohort trial. Participants will be recruited who are greater than 1 year post SCI. Abdominal FES will be applied to the abdominal muscles for eight week day bowel management (BM) sessions (which will last for the duration of the bowel routine for an estimated 30-60 minutes) over an estimated period of three to four weeks. This will be delivered by the participant pressing a button (where able) to trigger the FES when required, and by a carer or researcher when this is not possible

Specifically, Abdominal FES will be delivered, via electrodes placed over the posterolateral surface of the abdomen. The stimulation amplitude will initially be set to cause a strong visible muscle contraction (typically 60 - 80 mA). In addition, the stimulation amplitude will be evaluated every five minutes to ensure that stimulation is still tolerable and causing a suitable muscle contraction. A patient diary will also be used to monitor bowel management time for six sessions, prior to and also after the intervention period.
Intervention code [1] 319273 0
Treatment: Devices
Intervention code [2] 319274 0
Rehabilitation
Comparator / control treatment
Control period: participants or their carers will record the duration of six bowel routines immediately prior to the intervention period.

Intervention period: Together, researchers, participants and carers will record the duration of eight bowel routines, where they will receive Abdominal FES during and for 10 mins prior to their bowel routines.

Efficacy period: participants or their carers will record the duration of six bowel routines immediately post the intervention period.

Outcomes: Difference in average Bowel Management Time (BMT) between control period (no Abdominal FES) and active intervention (Abdominal FES)
Control group
Active

Outcomes
Primary outcome [1] 325979 0
Difference between the mean bowel management (BM) time measured during the six baseline control (no stimulation) BM sessions and the last 6 (75%) of the active BM (abdominal FES) sessions
BM time will be measured using a diary designed for this study by recording the start and end time of the routine based on consistent BM events, that have been agreed between the participant, researcher and carer.
Timepoint [1] 325979 0
First day of enrolment (pre-intervention), the day following the last day of the 6 bowel management sessions (efficacy period).
Secondary outcome [1] 389753 0
Quality of Life measured using the EQ-5D-5L Health Questionnaire
Timepoint [1] 389753 0
First day of enrolment (pre-intervention), the day following the last day of the 6 bowel management sessions (efficacy period).
Secondary outcome [2] 389755 0
bowel function measured using the International SCI bowel function basic data set questionnaire
Timepoint [2] 389755 0
First day of enrolment (pre-intervention), the day following the last day of the 6 bowel management sessions (efficacy period).
Secondary outcome [3] 389756 0
Composite measure of bowel management strategy measured via analysis of daily diary entries regarding bowel movements (time taken and frequency), Bristol stool scale, use of laxatives and manual procedures
Timepoint [3] 389756 0
On each day there is a bowel management session, for 6 control sessions, 8 intervention sessions, 6 efficacy sessions
Secondary outcome [4] 389762 0
bladder function measured using the Neurogenic Bladder Symptom Score
Timepoint [4] 389762 0
First day of enrolment (pre-intervention), the day following the last day of the 6 bowel management sessions (efficacy period).

Eligibility
Key inclusion criteria
- Chronic SCI (> 12 months since injury) above the level ofT8
- >= 18 years of age
- A measurable and consistent start and end bowel routine event
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- American Spinal Injuries Association Impairment Scale E
- Current bowel conditions such as irritable bowel syndrome, gastro-oesophagheal reflux, bowel obstruction, Crohn’s disease or diverticulitis
- Physical obstacles that prevent Abdominal FES (e.g. pregnancy, abdominal trauma, cardiac pacemaker or other implanted electromedical devices)
- No response to Abdominal FES (e.g. lower motor neuron impairment)
- Self-reported Bowel management time of <30 minutes
- Severely obese patients (>40 BMI)
- Lack of understanding of English
- Unable to give informed consent
- Previous history of recurrent episodes of AD
- Resting systolic blood pressure reported as > 140mmHg

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 required
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not required
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant variables will be presented using means and standard deviations for continuous normally distributed variables, medians and interquartile ranges for continuous non-normally distributed variables, and proportions and absolute numbers for categorical variables.
A paired T Test will be used to compare the primary outcome of BMT difference between control and intervention periods, when controlling for injury level, severity of injury (ASIA score) and age. Paired T Tests will also be used to compare secondary outcomes including bowel and bladder symptoms between conditions, when controlling for injury level, severity of injury (ASIA score) and age. An exploratory analysis will be used to investigate the effect of abdominal FES on quality of life and relations between bowel management (and medications) on BMT.
All adverse events will be recorded and summarised with descriptive statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
1/11/2022
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
34
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 18179 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 32226 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307396 0
Government body
Name [1] 307396 0
NSW Health
Country [1] 307396 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 308060 0
None
Name [1] 308060 0
Address [1] 308060 0
Country [1] 308060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307483 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 307483 0
Ethics committee country [1] 307483 0
Australia
Date submitted for ethics approval [1] 307483 0
11/02/2021
Approval date [1] 307483 0
19/03/2021
Ethics approval number [1] 307483 0
HC210106

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

Contacts
Principal investigator
Name 107390 0
Prof Simon Gandevia
Address 107390 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 107390 0
Australia
Phone 107390 0
+61 293991064
Fax 107390 0
Email 107390 0
[email protected]
Contact person for public queries
Name 107391 0
Keith McNaughton
Address 107391 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 107391 0
Australia
Phone 107391 0
+61 293991064
Fax 107391 0
Email 107391 0
[email protected]
Contact person for scientific queries
Name 107392 0
Keith McNaughton
Address 107392 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 107392 0
Australia
Phone 107392 0
+61 293991064
Fax 107392 0
Email 107392 0
[email protected]

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 post publication
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Abdominal Functional Electrical Stimulation for Improving Bowel Function in People With a Spinal Cord Injury: A Study Protocol for a Double-Blinded Randomized Placebo-Controlled Clinical Trial.2022https://dx.doi.org/10.46292/sci22-00008
N.B. These documents automatically identified may not have been verified by the study sponsor.