Randomised controlled trial of anal electrical stimulation in adults with faecal incontinence
| ISRCTN | ISRCTN92215924 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92215924 |
| Protocol serial number | AP0894 |
| Sponsor | Action Medical Research (UK) |
| Funder | Action Medical Research (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. One-week bowel diary |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Physiology Unit
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 | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No |
