Form 07 Randomization - SAS in Controlling Anal Incontinence by Performing Anal Exercises with Biofeedback or Loperamide: a Randomized Placebo Controlled Trial

Form 07 Randomization
Study Description
The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses: there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI; there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment; there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother. Women who seek treatment for fecal incontinence, also known as accidental bowel leakage.