Randomised controlled trial of anal electrical stimulation in adults with faecal incontinence
| ISRCTN | ISRCTN92215924 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92215924 |
| Secondary identifying numbers | AP0894 |
- Submission date
- 27/11/2001
- Registration date
- 27/11/2001
- 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) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Anal electric stimulation, used on a daily basis at home for eight weeks, would improve symptoms of faecal incontinence and anal sphincter pressures when compared with "sham" electric stimulation. |
| Ethics approval(s) | Harrow Research Ethics Committee gave approval. |
| Health condition(s) or problem(s) studied | Faecal incontinence |
| Intervention | Patient self-rating of change, bowel diary, bowel symptom questionnaire, quality of life, anal manometry |
| Intervention type | Other |
| Primary outcome measure | 1. One-week bowel diary 2. Symptom questionnaire 3. Manometry 4. Patients' evaluation of outcome |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2004 |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Adults (aged greater than or equal to 18 years, either sex) with faecal incontinence |
| Key exclusion criteria | 1. Patients refusing informed consent 2. Children under 18 years old 3. Pregnant females or those within six weeks of vaginal delivery 4. Patients with a history of pelvic malignancy 5. Patients with active inflammatory bowel disease 6. Patients with active perianal sepsis or painful haemorrhoids or fissure and patients with previous experience of using an electric stimulator to treat urinary or faecal incontinence |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2005 |
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
Not defined
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 | 01/02/2006 | Yes | No |
