Condition category
Digestive System
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
20/10/2010
Prospective/Retrospective
Prospectively 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

Ms Christine Norton

ORCID ID

Contact details

Physiology Unit
St Mark's Hospital
Watford Road
Harrow Middlesex
HA1 3UJ
United Kingdom
+44 (0)20 8235 4167
csnorton@aol.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP0679

Study information

Scientific title

Biofeedback for faecal incontinence: a randomised controlled trial

Acronym

Study hypothesis

Added 09/01/2009:
Behavioural treatment (biofeedback) improves faecal incontinence when compared to standard care.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Faecal incontinence

Intervention

Conservative management +/- biofeedback

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added 09/01/2009:
1. Diary
2. Symptom questionnaire
3. Continence score
4. Patient's rating of change
5. Quality of life (36-item Short-Form Health Survey [SF36] and disease specific)
6. Psychologic status (Hospital Anxiety and Depression Scale)
7. Anal manometry

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with faecal incontinence.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

171

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiology Unit
Harrow Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2003 results in http://www.ncbi.nlm.nih.gov/sites/pubmed/14598248

Publication citations

Additional files

Editorial Notes