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HYPOTHESIS: Permanent sacral nerve stimulation (SNS) is a promising emerging treatment for fecal incontinence. However, there is little data on morbidity and quality of life (QOL) during long-term stimulation. DESIGN: Prospective trial to assess morbidity and QOL in patients treated with SNS. Median follow-up was 13 months (range, 1-42 months). SETTING: University hospital providing primary, secondary, and tertiary care. PATIENTS: Between December 2001 and July 2005, SNS was tested in 44 patients (30 women), with a median age of 65 years (range, 15-88 years). INTERVENTIONS: Percutaneous nerve evaluation and permanent insertion of an implantable pulse generator. MAIN OUTCOME MEASURES: Morbidity, stool diary, and Wexner Score for fecal incontinence; Hanley Score for urinary incontinence; and Gastrointestinal Quality of Life Index, the 36-item short form health survey, and the Royal London Hospital questionnaire for QOL. RESULTS: A permanent stimulator was implanted in 37 patients (84%). Eight patients (22%) experienced complications that required surgical intervention. (A successful restimulation was possible for 5 of those patients.) Adverse effects of SNS were remedied in 5 patients by reprogramming the stimulator. Wexner Scores decreased from a median of 16 points preoperatively (range, 6-20), to a median of 5 points postoperatively (range, 0-13; P<.001). The median number of involuntary stool losses and for urge defecations also decreased significantly. Significant improvement in QOL was found in both generic and incontinence-specific questionnaires (P<.05). The success rate of SNS was 77% (34 of 44 patients) and 92% (34 of 37) in patients with permanent implantation. CONCLUSIONS: The minimally invasive technique of SNS is safe and effective. Most adverse effects can be easily remedied. Our data demonstrate that SNS significantly improves patients' QOL, including their physical and psychological well-being.