Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence.

Introduction: Treatment options for patients with fecal incontinence (FI) are limited, and surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe. A large multicenter trial was conducted in North America and Australia to assess the efficacy of SNS in patients with chronic fecal incontinence.

Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study.

Background: Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol.

Methods: Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial.