Biofeedback for faecal incontinence

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Christine Norton
Scientific

Physiology Unit
St Mark's Hospital
Watford Road
Harrow Middlesex
HA1 3UJ
United Kingdom

Phone	+44 (0)20 8235 4167
Email	csnorton@aol.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Biofeedback for faecal incontinence: a randomised controlled trial
Study objectives	Added 09/01/2009: Behavioural treatment (biofeedback) improves faecal incontinence when compared to standard care.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Faecal incontinence
Intervention	Conservative management +/- biofeedback
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	171
Key inclusion criteria	Adults with faecal incontinence.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2003
Date of final enrolment	01/06/2003

Physiology Unit

Harrow Middlesex
HA1 3UJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2003		Yes	No