Contact information
Type
Scientific
Primary contact
Mr ES Kiff
ORCID ID
Contact details
Department of General Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 6654
Julie.Adger@smuht.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0226118468
Study information
Scientific title
Acronym
Study hypothesis
1. How do treatments for faecal incontinence have effect?
2. Does biofeedback have a neuroplastic cortical effect in patients with faecal incontinence?
Ethics approval
Not provided at time of registration
Study design
Randomised, single-blinded, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nervous System Diseases: Neurogenic faecal incontinence
Intervention
Patients randomised to 1 of 3 groups, all will receive current biofeedback therapy, but at different time intervals:
1. Group 1 - Behaviour Modification - Baseline TMS - Behaviour Modification - TMS - Biofeedback - TMS
2. Group 2 - Biofeedback - Baseline TMS - Biofeedback - TMS
3. Group 3 - (Control) - Baseline TMS - repeat TMS - Biofeedback - TMS
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
To establish any cortical neuroplastic changes or nerve conduction changes in response to current treatments for faecal incontinence.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2002
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
30 Patients over the age of 18 with neurogenic faecal incontinence will be recruited from the referrals to Mr ES Kiff and 15 controls.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
01/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Surgery
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Manchester University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16044426
Publication citations
-
Results
Sheldon R, Kiff ES, Clarke A, Harris ML, Hamdy S, Sacral nerve stimulation reduces corticoanal excitability in patients with faecal incontinence., Br J Surg, 2005, 92, 11, 1423-1431, doi: 10.1002/bjs.5111.