Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/09/2013
Prospective/Retrospective
Retrospectively 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

Miss Nicky Horton

ORCID ID

Contact details

Department of Physiology
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
Middlesex
HA1 3UJ
United Kingdom
+44 (0) 20 8235 4172

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0515088411

Study information

Scientific title

Acronym

Study hypothesis

Biofeedback therapy leads to improved gut function and improved well being and is superior to standard laxative treatment.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

biofeedback versus laxatives

Primary outcome measures

Diaries, questionnaires, abdominal transit study.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2000

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

150 patients with 50 patients in each group, from age 18 years.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

150

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2000

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Physiology
Harrow, Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

North West London Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes