Fecal incontinence affects 2% of adults in the United States. Biofeedback has been
recommended for the treatment of fecal incontinence because uncontrolled studies over the
past 25 years suggest that these treatments are as effective as medical or surgical
management and involve no risk. However, placebo-controlled trials are still lacking.
The aims of this study are: (1) to compare biofeedback to alternative therapies for which
patients have a similar expectation of benefit; (2) to identify which patients are most
likely to benefit; and (3) to assess the impact of treatment on quality of life.
Study I is a long-term, prospective, single-blind study comparing biofeedback for fecal
incontinence to a standard therapy (Kegel exercises) that is associated with a similar
expectation of improvement (i.e., comparable placebo effect). Prior to randomization,
patients will receive medical therapy (antidiarrheal medications as appropriate) and
education for 4 weeks, and only patients who remain incontinent will be randomized. Anal
canal squeeze pressures and rectal sensory thresholds will be tested before and after
treatment. Patients will keep a diary throughout baseline and treatment, and they will be
re-assessed at 3, 6, and 12 months. Treatment will consist of 6 clinic visits at 2-week
intervals. The primary outcome is the patient's response to the question, "Have you had
satisfactory relief of fecal incontinence (yes/no)?" This question is asked at 3 months
following the end of treatment and at each follow-up visit. The investigators will develop a
detailed treatment manual for fecal incontinence which would permit other investigators to
replicate our study.
- Males or females age 16 or above who have an average of one or more episodes of fecal
incontinence per week
- Previous biofeedback treatment