Purpose: The use of sacral neuromodulation (SNM) to treat fecal incontinence (FI) has been officially approved in the EU since 1994 and the US since 2011. The purpose of this trial, the first prospective study conducted in Asia, was to determine the safety and efficacy of SNM in accordance with the government approval protocol in Japan.
Methods: Candidates for SNM who provided informed consent were enrolled in this institutional review board-approved multicenter prospective trial. Experiencing more than two incontinent episodes per week, not just staining, was part of the inclusion criteria. Patients showing >= 50% improvement during test stimulation received chronic implantation of the InterStim System (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that >= 50% of subjects would achieve therapeutic success, defined as >= 50% reduction of incontinent episodes per week at 6 months compared with baseline.
Results: A total of 22 patients underwent test stimulation with a 95% success rate, and 21 (12 females) with a mean age of 66.6 years and a mean duration of FI of 4.8 years received chronic implantation. At 6 months, 85.7% of subjects achieved therapeutic success (p=0.0007). Incontinent episodes significantly decreased from a mean of 14.9 per week at baseline to 3.1 at 6 months (p=0.0135). Anal manometry showed that preoperative maximum resting pressure (28.4mmHg) had significantly increased (39.1mmHg) at 6-month follow-up (p=0.0026). There were no reported unanticipated adverse device effects associated with InterStim Therapy.
Conclusions: SNM using InterStim System is a safe and effective treatment for Japanese patients with FI.
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