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ISRCTN
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ISRCTN45147456
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DOI
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10.1186/ISRCTN45147456
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Biofeedback for faecal incontinence
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Scientific title
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Biofeedback for faecal incontinence: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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AP0679
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Study hypothesis
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Added 09/01/2009:
Behavioural treatment (biofeedback) improves faecal incontinence when compared to standard care.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Faecal incontinence
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Participants - inclusion criteria
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Adults with faecal incontinence.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2003
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Anticipated end date
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01/06/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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171
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Interventions
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Conservative management +/- biofeedback
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/sites/pubmed/14598248
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Contact name
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Ms
Christine
Norton
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Address
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Physiology Unit
St Mark's Hospital
Watford Road
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City/town
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Harrow Middlesex
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Zip/Postcode
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HA1 3UJ
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Country
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United Kingdom
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Tel
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+44 (0)20 8235 4167
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Fax
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+44 (0)20 8235 4162
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Email
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csnorton@aol.com
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Tel
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+44 (0)1403 210 406
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Fax
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+44 (0)1403 210 541
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Email
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info@actionresearch.co.uk
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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20/10/2010
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Date ISRCTN assigned
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01/03/2001
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