BACKGROUND AND OBJECTIVE: Sacral nerve stimulation is effective in the treatment of urinary incontinence and is currently under Food and Drug Administration review in the United States for fecal incontinence. Previous reports have focused primarily on short-term results of sacral nerve stimulation for fecal incontinence. The present study reports the long-term effectiveness and safety of sacral nerve stimulation for fecal incontinence in a large prospective multicenter study.
DESIGN AND METHODS: Patients with fecal incontinent episodes more than twice per week were offered participation in this multicentered prospective trial. Patients showing ≥50% improvement during test stimulation were offered chronic implantation of the InterStim Therapy system (Medtronic; Minneapolis, MN). The aims of the current report were to provide 3-year follow-up data on patients from that study who underwent sacral nerve stimulation and were monitored under the rigors of an Food and Drug Administration-approved investigational protocol.
RESULTS: One hundred thirty-three patients underwent test stimulation with a 90% success rate, of whom 120 (110 females) with a mean age of 60.5 years and a mean duration of fecal incontinence of 7 years received chronic implantation. Mean length of follow-up was 3.1 (range, 0.2–6.1) years, with 83 patients completing all or part of the 3-year follow-up assessment. At 3 years follow-up, 86% of patients (P < .0001) reported ≥50% reduction in the number of incontinent episodes per week compared with baseline and the number of incontinent episodes per week decreased from a mean of 9.4 at baseline to 1.7. Perfect continence was achieved in 40% of subjects. The therapy also improved the fecal incontinence severity index. Sacral nerve stimulation had a positive impact on the quality of life, as evidenced by significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument at 12, 24, and 36 months of follow-up. The most common device- or therapy-related adverse events through the mean 36 months of follow-up included implant site pain (28%), paresthesia (15%), change in the sensation of stimulation (12%), and infection (10%). There were no reported unanticipated adverse device effects associated with sacral nerve stimulation therapy.
CONCLUSIONS: Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with fecal incontinence. These data support long-term safety and effectiveness to 36 months.
1 Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, Minnesota
2 Department of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida
3 Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, Massachusetts
4 Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Fleurimont, Canada
5 Medtronic, Inc., Minneapolis, Minnesota
6 Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio
Financial Disclosures: Dr Mellgren has received honoraria and research support from Medtronic. Other entity affiliations are as follows: American Medical Systems (research support, consultant), Q-Med Scandinavia (research support, consultant), Carbon Medical (research support), Torax Medical (research support, consultant), Tsumara USA Inc. (consultant). Dr Wexner is a consultant in the field of fecal incontinence for Ethicon, Inc., Incontinent Devices Corp. CRBard, Covidien, and after the conclusion and presentation of this study by Medtronic. He is also a consultant for Adolor/Glaxco Smith Kline, century Medical (Japan), EZ Surgical (Israel), Karl Storz Endoscopy, LifeCell, Neatstitch (Israel), Niti (Israel), and Signalomics (Germany). He has stock options in EZ Surgical, Intuitive Surgical, Neatstitch, and SurgRx. He has the right to inventors' share income from Advanced Surgical Innovations, Covidien, Karl Storz Endoscopy, Unique Surgical Innovations. Dr Coller is coinvestigator on this current Medtronic-funded study. Dr Devroede has no financial disclosures to be acknowledged. Dr Lerew is an employee of Medtronic, Inc. Dr Madoff is a consultant for Medtronic, Torax Medical, American Medical Systems, Tsumara USA Inc. Dr Hull has received Grant/Research Support from Medtronic.
Presented at the meeting of The American Society of Colon and Rectal Surgeons, Minneapolis, MN, May 15 to 19, 2010.
Correspondence: Anders Mellgren, M.D., Ph.D., Colon and Rectal Surgery Associates, 2800 Chicago Ave S, #300, Minneapolis, MN 55407. E-mail: email@example.com