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Purpose: Sacral nerve stimulation (SNS) is effective in the treatment of urinary incontinence and is currently under review by the FDA for the treatment of fecal incontinence (FI) in subjects who have failed or are not candidates for other treatments. The aim of this study was to analyze the results of patients with FI treated with SNS in a large prospective clinical trial to identify any potential predictors of therapeutic success 3 years after implant. Methods: Patients with >/= 50% improvement in FI episodes and/or days per week during a 10-14 day test stimulation period using the chronic lead were implanted with a Medtronic InterStim neurostimulator. This analysis compared patients who had >/= 50% improvement in FI episodes per week (success) to patients who had < 50% improvement at 3 years. Baseline demographics were compared between the groups including age, gender, BMI, duration, severity, type, and etiology of FI, number of pregnancies and deliveries, irritable bowel syndrome, internal and external anal sphincter defects, prior surgeries, and quality of life. Results: 66 of the 77 subjects (86%) achieved therapeutic success with a median reduction of 96% in episodes of FI; 31 (40%) patients achieved complete continence. Only 11 patients (14%) did not meet the >/= 50% criterion for success with a median reduction of 30% in FI episodes. Improvement in FI episodes during test stimulation was greater in subjects with therapeutic success (88%) than in those without success (75%) (p=0.02). No other differences were noted between the groups.Conclusion: The present analysis indicates that the therapy was effective but that the only factor which correlated with success at 3 years was improvement during test stimulation.