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Trial registered on ANZCTR


Registration number
ACTRN12615001334594
Ethics application status
Approved
Date submitted
29/11/2015
Date registered
7/12/2015
Date last updated
7/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central brain responses of sacral nerve stimulation in patients with faecal incontinence
Scientific title
A prospective experimental study investigating the impact of sacral nerve stimulation on brain activity in patients with faecal incontinence
Secondary ID [1] 286553 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal incontinence 294800 0
Functional bowel disorders 296896 0
Condition category
Condition code
Oral and Gastrointestinal 295077 295077 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 297150 297150 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
This is an observational study, the exposure is acquisition of brain images using fMRI.
Sacral nerve stimulator is a pacemaker like device implanted in the buttock and connected to leads that are placed in the S3 or S4 foramina percutaneously.
fMRI involves acquisition of images whilst providing a visceral stimulus i.e. rectal balloon distension. This is performed at baseline and 6 weeks post device implantation.
Intervention code [1] 291660 0
Not applicable
Comparator / control treatment
Patients' baseline measurements will act as the control measurements for each participant
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294841 0
Changes in brain activity with the device switched on, as assessed using functional MRI
Timepoint [1] 294841 0
At baseline and 6 weeks post implantation of sacral nerve stimulator
Secondary outcome [1] 314182 0
Changes in resting state brain activity, assessed by fMRI
Timepoint [1] 314182 0
At baseline and 6 weeks post implantation of device

Eligibility
Key inclusion criteria
1. Age >18 years
2. Predominant symptom: Faecal Incontinence
3. Have no contraindications to MRI
4. Participants already scheduled to be treated by sacral nerve stimulation

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-English speaking
2. Cognitive impairment
3. CI to MRI e.g. claustrophobia
4. Major Psychological Disorders (eg. Major Depression, Major Anxiety, Schizophrenia, Bipolar)
4. Pregnancy
5. Neurological disorders e.g. Spina Bifida, Multiple Sclerosis, Parkinson disease.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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

Funding & Sponsors
Funding source category [1] 291117 0
Self funded/Unfunded
Name [1] 291117 0
Professor Marc Gladman
Address [1] 291117 0
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
NSW 2139
Country [1] 291117 0
Australia
Primary sponsor type
Individual
Name
Professor Marc Gladman
Address
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
NSW 2139
Australia
Country
Australia
Secondary sponsor category [1] 289793 0
Individual
Name [1] 289793 0
Dr Naseem Mirbagheri
Address [1] 289793 0
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
NSW 2139
Australia
Country [1] 289793 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292698 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 292698 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 292698 0
Australia
Date submitted for ethics approval [1] 292698 0
17/06/2014
Approval date [1] 292698 0
06/12/2014
Ethics approval number [1] 292698 0
2014/494

Summary
Brief summary
Sacral Nerve Stimulation(SNS) has revolutionised the management of urinary and faecal incontinence over the past 20 years. SNS is now embraced worldwide as a first line treatment for patients with urinary and faecal incontinence in whom conservative measures have failed. However, despite extensive experience with the stimulator and research in the field, its mechanism(s) of action remains elusive. Recently it has been suggested that SNS works by changing the way the brain functions by 'restarting' its normal function, akin to 'restarting a computer'. In this study we aim to lend scientific support for this hypothesis by investigating the impact of SNS on brain function using functional MRI (fMRI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56190 0
Prof Marc A Gladman
Address 56190 0
Academic Colorectal Unit Concord Repatriation General Hospital 1st Floor
Clinical Science Building Building 20 Hospital Road NSW 2139 Australia
Country 56190 0
Australia
Phone 56190 0
+61 2 97676928
Fax 56190 0
Email 56190 0
m.a.gladman@sydney.edu.au
Contact person for public queries
Name 56191 0
Dr Naseem Mirbagheri
Address 56191 0
Academic Colorectal Unit Concord Repatriation General Hospital 1st Floor
Clinical Science Building Building 20 Hospital Road NSW 2139 Australia
Country 56191 0
Australia
Phone 56191 0
+61 2 97676928
Fax 56191 0
Email 56191 0
nmir9508@uni.sydney.edu.au
Contact person for scientific queries
Name 56192 0
Dr Naseem Mirbagheri
Address 56192 0
Academic Colorectal Unit Concord Repatriation General Hospital 1st Floor
Clinical Science Building Building 20 Hospital Road NSW 2139 Australia
Country 56192 0
Australia
Phone 56192 0
+61 2 97676928
Fax 56192 0
Email 56192 0
nmir9508@uni.sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary