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 measure
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 (if study stopped)
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
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 organizations
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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/sites/pubmed/14598248