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Trial registered on ANZCTR


Registration number
ACTRN12615000786594
Ethics application status
Approved
Date submitted
11/07/2015
Date registered
29/07/2015
Date last updated
29/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical and Physiological Impact of Interrupting Sacral Neuromodulation Therapy in Patients with Faecal Incontinence
Scientific title
A Double-Blind Randomised Crossover Trial to Determine the Clinical and Physiological Impact of Temporarily Interrupting Sacral Neuromodulation in Patients with Faecal Incontinence
Secondary ID [1] 286449 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Faecal Incontinence 294621 0
Functional Bowel Disorders 294622 0
Condition category
Condition code
Surgery 294924 294924 0 0
Other surgery
Oral and Gastrointestinal 295910 295910 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 295911 295911 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is to switch off the neuromodulation device which is the implanted pulse generator that stimulates the sacral nerve. The device is switched off for 6 weeks by a nurse. To monitor adherence to the intervention the remote control which the patient usually uses to turn their device off or on is placed in a security sealed envelope. Each cycle includes 2 weeks of washout period.
Intervention code [1] 291527 0
Treatment: Devices
Intervention code [2] 292354 0
Treatment: Other
Comparator / control treatment
Patients will act as their own control for this study using a blinded, crossover design.The control treatment refers to when the device is switched on for the 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294678 0
Mean number of incontinence episodes per week as assessed by patient filled bowel chart diaries

Timepoint [1] 294678 0
Baseline
6 weeks
12 weeks
Primary outcome [2] 295587 0
Incontinence severity score as assessed by validated questions on bowel function (Vaizey Incontinence Score)
Timepoint [2] 295587 0
Baseline
6 weeks
12 weeks
Primary outcome [3] 295588 0
Quality of life scores as assessed using validated questionnaires that include SF-36 health survey and Faecal Incontinence specific Quality of Life score (FIQL)
Timepoint [3] 295588 0
Baseline
6 weeks
12 weeks
Secondary outcome [1] 313859 0
Anal pressures measured using High Resolution Anal Manometry equipment (primary outcome)
Timepoint [1] 313859 0
Baseline
6 weeks
12 weeks
Secondary outcome [2] 315900 0
Rectal sensory thresholds and compliance using a barostat device (primary outcome)
Timepoint [2] 315900 0
Baseline
6 weeks
12 weeks
Secondary outcome [3] 315901 0
Mean number of soiling per week as assessed by patient filled bowel chart diary
Timepoint [3] 315901 0
Baseline
6 weeks
12weeks
Secondary outcome [4] 315902 0
Faecal urgency (ability to postpone defaection) as assessed by patient filled bowel chart diary (measured in minutes)
Timepoint [4] 315902 0
Baseline
6 weeks
12 weeks

Eligibility
Key inclusion criteria
1. Age >18 years
2. Predominant symptom: faecal Incontinence
3. Have been implanted with a permanent sacral nerve stimulator for at least 6 months
4. Subjective improvement in symptoms of faecal incontinence compared to baseline (i.e prior to the implantation of the stimulation device)
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. Non-ambulatory
4. Pregnancy
5. Neurological disorders e.g. Spina Bifida or Multiple Sclerosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients implanted with a permanent sacral nerve stimulator at Concord Hospital will be assessed for eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A specialist nurse, who is otherwise not involved with data collection and analysis will undertake all randomisation. Both the investigators and the patients are blinded to randomisation arm assigned. A computer generated block randomisation will be performed and sealed in an opaque envelope. The envelopes are numbered and drawn sequentially at the point of randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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
Recruitment hospital [1] 3623 0
Concord Repatriation Hospital - Concord

Funding & Sponsors
Funding source category [1] 291016 0
Self funded/Unfunded
Name [1] 291016 0
Professor Marc A Gladman
Address [1] 291016 0
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
Concord
NSW 2139
Country [1] 291016 0
Australia
Primary sponsor type
Individual
Name
Professor Marc A Gladman
Address
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
Concord
NSW 2139
Australia
Country
Australia
Secondary sponsor category [1] 289692 0
Individual
Name [1] 289692 0
Dr Naseem Mirbagheri
Address [1] 289692 0
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
Concord
NSW 2139
Australia
Country [1] 289692 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292600 0
Sydney Local Health District
Ethics committee address [1] 292600 0
Human Research Ethics Committee
Building 20
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Ethics committee country [1] 292600 0
Australia
Date submitted for ethics approval [1] 292600 0
02/05/2013
Approval date [1] 292600 0
06/06/2013
Ethics approval number [1] 292600 0
13/CRGH/75

Summary
Brief summary
Sacral Neuromodulation or SNM is a well-established treatment for bowel leakage, also known as faecal incontinence. It uses a small device (a stimulator) that is implanted under the skin in the upper buttock area. It then transmits electrical pulses through a small wire that is positioned close to the sacral nerve to improve bowel control and function. Despite being very successful for the treatment of faecal incontinence, the exact mechanism by which it works remains unknown. It is possible that SNM influences the way that the brain and gut interact by ‘resetting’ its function back to normal, a bit like restarting a computer after it ‘crashes’. If this is true, long-term SNM may not be necessary to control symptoms.

The aim of this study is to assess the impact of SNM on bowel symptoms and bowel control, particularly when SNM is switched off. The group studied will include patients with faecal incontinence who have successfully been stimulated for at least 6 months.

A total of 20 patients will be recruited and randomised into two groups; each group will have two cycles of different exposure. Each cycle will last for 6 weeks and will involve either turning the stimulator Off or On. Patients and assessors will be unaware whether the stimulator is On or Off, so as to reduce the effect of bias. At each 6-week cycle, all patients recruited will attend the hospital to adjust their stimulator and to complete a questionnaire and undergo physiology tests to measure bowel control and function. At the end of the study the SNM will be switched back to the original setting.

Study outcomes will involve assessment of bowel symptoms, severity of faecal incontinence, quality of life scores and anorectal physiological function. This study will provide important information in understanding and treating disorders of bowel function and bowel leakage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56166 0
Dr Naseem Mirbagheri
Address 56166 0
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
Concord
NSW 2139
Australia
Country 56166 0
Australia
Phone 56166 0
+61 2 97676928
Fax 56166 0
Email 56166 0
nasmir79@gmail.com
Contact person for public queries
Name 56167 0
Dr Naseem Mirbagheri
Address 56167 0
Academic Colorectal Unit
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
Concord
NSW 2139
Australia
Country 56167 0
Australia
Phone 56167 0
+61 2 97676928
Fax 56167 0
Email 56167 0
nmir9508@uni.sydney.edu.au
Contact person for scientific queries
Name 56168 0
Prof Marc A Gladman
Address 56168 0
Concord Repatriation General Hospital
1st Floor Clinical Science Building
Building 20
Hospital Road
Concord
NSW 2139
Australia
Country 56168 0
Australia
Phone 56168 0
+61 2 97676928
Fax 56168 0
Email 56168 0
m.a.gladman@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