A randomised controlled trial of biofeedback versus laxatives for chronic idiopathic constipation in women

ISRCTN	ISRCTN35017966
DOI	https://doi.org/10.1186/ISRCTN35017966
Secondary identifying numbers	N0515088411

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 24/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Nicky Horton
Scientific

Department of Physiology
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow, Middlesex
HA1 3UJ
United Kingdom

Phone	+44 (0) 20 8235 4172

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	Biofeedback therapy leads to improved gut function and improved well being and is superior to standard laxative treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Constipation
Intervention	Group 1: Single patients 60 min session involving a detailed history of the patient. Advice given on diet and defaecatory posture. Gut function explained and defaecatory exercises demonstrated using balloon expulsion. Patients will practice exercises at home. Laxatives stopped. Followed up at 16 weeks. Group 2: The same assessment as Group 1 with the same advice and information. Four subsequent 30-40 min sessions at 4 weekly intervals with the same Biofeedback Nurse to practice balloon expulsion and reinforce information. Group 3: The same assessment as Group 1 with the same advice on diet, etc, but no information on gut function or defaecatory dynamics and no Biofeedback exercises. Patients will be commenced on Bisacodyl 1-2 at night increasing up to 3 at night if required. In addition they will be allowed to use suppositories as required. Four subsequent 30-40 min sessions at 4 weekly intervals with the same Biofeedback Nurse to discuss laxative titration and reinforce information and advice. All patients will be assessed at 4 and 12 months after commencing treatment. Patients from Groups 1 and 3 can cross over to Group 2 if they are not satisfied with the outcome at 4 months after commencing treatment.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	biofeedback versus laxatives
Primary outcome measure	Diaries, questionnaires, abdominal transit study.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2000
Completion date	30/06/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	150
Key inclusion criteria	150 patients with 50 patients in each group, from age 18 years.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/2000
Date of final enrolment	30/06/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Physiology

Harrow, Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan