Randomized, Controlled Trial of Biofeedback for Fecal Incontinence

Abstract & Commentary

Synopsis: In this study, fecal incontinence therapies, including standard care (advice), sphincter exercises, and computer-assisted biofeedback, all led to substantial improvements in continence, quality of life, psychological well being, and sphincter function with no evidence of superiority for biofeedback.

Source: Norton C, et al. Gastroenterology. 2003;125:1320-1329.

Fecal incontinence is a dreaded condition. a UK study found that 5.7% of women and 6.2% of men older than 40 described some degree of fecal incontinence. Various behavioral approaches to fecal incontinence have been described, including considerable enthusiasm for biofeedback in this socially disastrous and demoralizing condition—but without comparison of such techniques to standard care.

Metaanalyses have suggested that 48.6% of patients could be cured using biofeedback, and 71.7% were improved. However, a Cochrane review was less sanguine about the believability of these data. Norton and colleagues at St. Marks Hospital in England have undertaken a carefully randomized study of patients with fecal incontinence who had not undergone prior biofeedback. Two subgroups were selected: those with and without evidence for anatomic anal sphincter damage by ultrasound; 171 patients were randomized.

Therapeutic groups were: 1) nine 40-60 minute sessions with a specialist nurse who advised patients about lifestyle, diet fluids, techniques to improve evacuation, and titration of prescribed antidiarrheal medications; 2) all of the prior maneuvers plus detailed digital exam-based sphincter exercise instruction; 3) all of the above plus computer-assisted biofeedback during the training sessions (increasing rectal sensitivity to distention, improved coordination, etc); and 4) all of the prior interventions plus use of an at-home biofeedback device to enhance sphincter contractions. Outcomes in a predetermined sample size for power evaluated included patient satisfaction scores, objective measures of sphincter function, and careful scoring of symptom frequency/severity. Perhaps surprising to some, there were no advantages found with any of the interventions beyond standard care as in group 1. However, all patient groups statistically responded to therapy subjectively and also in terms of the objective criteria used. More than 50% of all patients achieved some benefit. This is still a labor-intensive and lengthy process, but it was deemed to be clearly worthwhile for a great many of these otherwise miserable patients.

Comment Malcolm Robinson, MD, FACP, FACG

This paper runs counter to the modern expectation that more technology is invariably better than simple clinical interventions. To paraphrase Voltaire’s comments in the 18th Century, the physician’s job may be to amuse the patient while nature cures the disease—but there is increasing evidence that physician-patient and nurse-patient relationships are themselves potentially intensely therapeutic.

Dr. Robinson, Medical Director, Oklahoma Foundation for Digestive Research; Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK, is Associate Editor of Internal Medicine Alert.