Condition category
Digestive System
Date applied
27/11/2001
Date assigned
27/11/2001
Last edited
20/10/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.action.org.uk/

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

  1. 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.

Additional files

Editorial Notes