A randomised controlled trial of biofeedback versus laxatives for chronic idiopathic constipation in women
| ISRCTN | ISRCTN35017966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35017966 |
| Protocol serial number | N0515088411 |
| Sponsor | Department of Health (UK) |
| Funder | North West London Hospitals NHS Trust (UK) |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | biofeedback versus laxatives |
| Primary outcome measure(s) |
Diaries, questionnaires, abdominal transit study. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Physiology
Harrow, Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
