RANDOMIZED CONTROLLED TRIALS Efficacy of Sacral Nerve Stimulation for Fecal Incontinence Results of a Multicenter Double-Blind Crossover Study

study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients. Methods: A total of 34 consecutive patients (31 women), median age 57 years (range, 33–73 years), underwent sacral nerve stimulation for fecal incontinence. After implantation, 27 of 34 patients were random-ized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. While still blinded, the patients chose the period of stimulation (ON or OFF) that they had preferred. The mode of stimu-lation corresponding to the selected period was continued for 3 months (final period). Outcome measures were frequency of fecal incontinence and urgency episodes, delay in postponing defecation, score severity, feeling of improvement, preference for ON or OFF, quality of life, and manometric measurements. Results: In the crossover portion of the study, the self-reported frequency of fecal incontinence episodes was significantly reduce