Imodium Syrup Versus Imodium Tablets for Faecal Incontinence
Status:
Withdrawn
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
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 from FI with prevalence increasing with age, further to this up to 50% of
nursing home residents suffer too with it more common in females. Aetiology is often
multi-factoral, where obstetric anal sphincter injury is most common is females and
iatrogenic anal sphincter injury is most common in males.
Loperamide (imodium) is a constipating agent used as first choice pharmacological agent due
to its high efficacy. Trials have suggested it thickens stool consistency and may raise
resting anal sphincter pressure, associated with improved clinical function with a reduction
in bowel frequency and urgency, a reduction in incontinence and less need for pads.
Loperamide is well tolerated but has been known to cause side effects of abdominal pain and
distension, nausea and vomiting and constipation.
Imodium can be taken in two ways; as syrup (1mg/5mls) or tablets (2mg). There have been no
comparative studies. Side effects are mainly seen with the tablet form and so it is
hypothesized that the syrup form is better tolerated because it is more accurately titrated
to effect.
This is a NHS funded single blinded, randomised, cross-over study to assess the clinical
effects of Imodium, in tablet and syrup form, on patients presenting with faecal
incontinence. Each subject will act as their own control. Patients will be recruited through
out-patient visits for their FI, where they will be made aware of the trial. During the trial
they will be asked to fill out FI scoring questionnaires and quality of life scores. Also
they will undertake two assessments of anal physiology testing squeeze pressures, sensation
and compliance at baseline and at the end after three months.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust