The aim of the study is to test the hypothesis that topical application of phenylephrine improves faecal continence and quality of life in subjects with passive faecal incontinence after ileo-anal pouch construction.
Faecal seepage and even frank incontinence at night can be a problem for approximately 30% of patients who have undergone ileal pouch anal anastomosis (IPAA). Nocturnal seepage may be a problem in patients who do not have gross incontinence, or who may even have no incontinence during the day. Although baseline continence during the day is maintained by involuntary control of the internal anal sphincter, this can be supplemented by voluntary contraction of the external sphincter. While sleeping, this supplementary external sphincter effect is lost and internal anal sphincter tone is reduced, leading to seepage. This is obviously distressing and leads some patients to wear a pad to reduce the soiling that may occur. The primary objective is to determine the effect of 10% phenylephrine hydrochloride gel, applied three times a day, on the change from baseline to the end of study (8 weeks)in the faecal incontinence score (St Mark's) with passive faecal incontinence after ileo-anal pouch construction, compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
St Mark's Hospital
Harrow, Middlesex, United Kingdom
The primary efficacy variable will be the change from baseline to the end of study in the faecal incontinence score (St Mark's)
Efficacy:
Number of daytime faecal incontinence episodes of liquid/mucus and solid stool
Number of nights with nocturnal incontinence episodes of liquid/mucus and solid stool
Number of incontinence episodes of gas
Faecal incontinence quality of life scale
Subject satisfaction with treatment
Subject assessment of overall change from baseline
Loperamide or other constipating agent usage
Anal manometry measurements
Safety:
AEs
Blood pressure
Pulse rate
Changes in other physical examination findings
Changes in biochemical or haematological markers
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