Biofeedback for faecal incontinence
| ISRCTN | ISRCTN45147456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45147456 |
| Secondary identifying numbers | AP0679 |
- Submission date
- 01/03/2001
- Registration date
- 01/03/2001
- Last edited
- 20/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Christine Norton
Scientific
Scientific
Physiology Unit
St Mark's Hospital
Watford Road
Harrow Middlesex
HA1 3UJ
United Kingdom
| Phone | +44 (0)20 8235 4167 |
|---|---|
| csnorton@aol.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Physiology Unit
Harrow Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Action Medical Research (UK)
Charity
Charity
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
| Website | http://www.action.org.uk/ |
|---|---|
"ROR" |
https://ror.org/01wcqa315 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2003 | Yes | No |
