Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

University Hospital Southampton NHS Foundation Trust

Status and phase: Withdrawn; Phase 4

Conditions: Fecal Incontinence

Treatments: Drug: Imodium (Loperamide Hydrochloride) syrup; Drug: Imodium (Loperamide hydrochloride) tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT00933465

eudraCT number 2009-013776-49;

RHMMED0874

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

tablets first followed by syrup

Experimental group

Description:

first 6 weeks of study using tablets, then followed by assessment, and then the next 6 weeks using syrup, followed by assessment

Treatment:

Drug: Imodium (Loperamide Hydrochloride) syrup

Drug: Imodium (Loperamide hydrochloride) tablets

Syrup first followed by tablets

Experimental group

Description:

first 6 weeks of study using syrup, then followed by assessment, and then the next 6 weeks using tablets, followed by assessment

Treatment:

Drug: Imodium (Loperamide Hydrochloride) syrup

Drug: Imodium (Loperamide hydrochloride) tablets