Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes