Transcutaneous magnetic cortical stimulation (TMS) for assessment of the external anal sphincter in neurogenic faecal incontinence

ISRCTN	ISRCTN03140344
DOI	https://doi.org/10.1186/ISRCTN03140344
Secondary identifying numbers	N0226118468

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr ES Kiff
Scientific

Department of General Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone	+44 (0)161 291 6654
Email	Julie.Adger@smuht.nwest.nhs.uk

Study design	Randomised, single-blinded, controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	1. How do treatments for faecal incontinence have effect? 2. Does biofeedback have a neuroplastic cortical effect in patients with faecal incontinence?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2002
Completion date	01/10/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	45
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2002
Date of final enrolment	01/10/2004

Department of General Surgery

Manchester
M23 9LT
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

South Manchester University Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2005		Yes	No