Status:
WITHDRAWN
Imodium Syrup Versus Imodium Tablets for Faecal Incontinence
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
University of Southampton
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Faecal incontinence (FI) is a debilitating and often neglected problem. It can be defined as the loss of voluntary control of liquid or solid stool.It is estimated that 2-3% of western adults suffer f...
Eligibility Criteria
Inclusion
- Aged 18 - 75
- Severe faecal incontinence defined as greater than one episode per week of involuntary loss of either solid or liquid stool as demonstrated by means of a baseline bowel habit and a Vaizey score of greater than 4.
- Competent and willing to fill in questionnaires and attend follow up clinics through out the study period.
Exclusion
- Alternating bowel habit, associated with symptoms of constipation. Use of other regular or as required medications that may affect bowel function. (e.g. codeine phosphate).
- Patients with complete or partial spinal cord injuries including cauda equina syndrome.
- Active inflammatory bowel disease.
- Pregnancy
- Stoma in situ
- Psychiatric and physiological inability to comply with study protocol.
- Non english speakers (student project funding cannot cover interpreter and other costs)
- (application of criteria at the discretion of the investigating doctor at initial consultation)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00933465
Start Date
October 1 2009
End Date
May 1 2010
Last Update
November 18 2014
Active Locations (1)
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1
Southampton General Hospital
Southampton, Hampshire, United Kingdom, so16 6YD