INTRODUCTION:Fecal incontinence is experienced by some patients with an ileoanal reservoir pouch. The alpha1-adrenergic agonist phenylephrine raises resting anal sphincter pressure in healthy volunteers and may be of value in these patients. METHODS:Twelve patients (7 female), median age 44 (range, 29-67) years were studied. All had fecal incontinence despite a noninflamed pouch of normal size and ultrasonographically structurally normal anal sphincter muscles. Patients were treated with topical 10 percent phenylephrine and placebo gels, allocated in random order in a double-blind, crossover study for two four-week periods. Before and during treatment, maximum resting anal sphincter pressure and anodermal blood flow were measured, a symptom questionnaire was completed, and incontinence score was determined using a validated scale. RESULTS: Six of 12 (50 percent) patients improved subjectively after phenylephrine compared with one on placebo (P = 0.07). Four patients had complete cessation of incontinence with active treatment. Phenylephrine significantly reduced the incontinence score (P = 0.015). It also resulted in a significant rise in mean maximum resting anal sphincter pressure when compared with placebo (P = 0.012). For all 12 patients, mean percent subjective improvement was higher after phenylephrine compared with placebo (P = 0.04). There were no side effects. CONCLUSIONS:Topical phenylephrine significantly improves fecal continence in patients with an ileoanal pouch. In some patients it totally eliminates nocturnal episodes. The mechanism of benefit is likely to be one of altered neural sphincter control. This is the first study of the use of a topical pharmacologic agent to treat fecal incontinence and may have a wider application.
RCT Entities:
INTRODUCTION: Fecal incontinence is experienced by some patients with an ileoanal reservoir pouch. The alpha1-adrenergic agonist phenylephrine raises resting anal sphincter pressure in healthy volunteers and may be of value in these patients. METHODS: Twelve patients (7 female), median age 44 (range, 29-67) years were studied. All had fecal incontinence despite a noninflamed pouch of normal size and ultrasonographically structurally normal anal sphincter muscles. Patients were treated with topical 10 percent phenylephrine and placebo gels, allocated in random order in a double-blind, crossover study for two four-week periods. Before and during treatment, maximum resting anal sphincter pressure and anodermal blood flow were measured, a symptom questionnaire was completed, and incontinence score was determined using a validated scale. RESULTS: Six of 12 (50 percent) patients improved subjectively after phenylephrine compared with one on placebo (P = 0.07). Four patients had complete cessation of incontinence with active treatment. Phenylephrine significantly reduced the incontinence score (P = 0.015). It also resulted in a significant rise in mean maximum resting anal sphincter pressure when compared with placebo (P = 0.012). For all 12 patients, mean percent subjective improvement was higher after phenylephrine compared with placebo (P = 0.04). There were no side effects. CONCLUSIONS: Topical phenylephrine significantly improves fecal continence in patients with an ileoanal pouch. In some patients it totally eliminates nocturnal episodes. The mechanism of benefit is likely to be one of altered neural sphincter control. This is the first study of the use of a topical pharmacologic agent to treat fecal incontinence and may have a wider application.
Authors: Changyoon Baek; MeeRee Han; Junhong Min; Mark R Prausnitz; Jung-Hwan Park; Jung Ho Park Journal: J Control Release Date: 2011-05-07 Impact factor: 9.776