Contact information
Type
Scientific
Primary contact
Ms Christine Norton
ORCID ID
Contact details
Physiology Unit
St Mark's Hospital
Watford Road
Harrow Middlesex
HA1 3UJ
United Kingdom
+44 (0)20 8235 4167
csnorton@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0894
Study information
Scientific title
Acronym
Study hypothesis
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
Harrow Research Ethics Committee gave approval.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Faecal incontinence
Intervention
Patient self-rating of change, bowel diary, bowel symptom questionnaire, quality of life, anal manometry
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. One-week bowel diary
2. Symptom questionnaire
3. Manometry
4. Patients' evaluation of outcome
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2004
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Adults (aged greater than or equal to 18 years, either sex) with faecal incontinence
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
01/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Physiology Unit
Harrow Middlesex
HA1 3UJ
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Not defined
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16362803
Publication citations
-
Results
Norton C, Gibbs A, Kamm MA, Randomized, controlled trial of anal electrical stimulation for fecal incontinence., Dis. Colon Rectum, 2006, 49, 2, 190-196, doi: 10.1007/s10350-005-0251-1.