The aim of the present analysis was to report on the relationship between long-term improvement in quality of life (QOL) and fecal incontinence (FI) severity and long-term reduction in FI episodes after sacral nerve stimulation (SNS) or sacral neuromodulation.
Patients who met inclusion/exclusion criteria, and initially had more than 2 FI episodes per week, were offered SNS therapy. Patients with 50% or higher reduction in FI during a 2-week test period were implanted with a neurostimulator (InterStim; Medtronic, Minneapolis, Minn). Assessments were completed by patients at baseline and at 3, 6, and 12 months after implant, and annually thereafter. The present report includes data from the 4-year postimplant follow-up.
A total of 133 patients underwent test stimulation with a 90% success rate, and as a result, 120 (110 females) with a mean age of 60.5 years and a mean duration of FI of 6.8 years received long-term implantation. Of them, 78 patients completed all or part of the 4-year follow-up assessment. Fecal incontinence episodes decreased from a mean of 9.4 per week at baseline to 1.9 per week at 48 months (P < 0.001). The 4-year analyses showed that SNS had a positive and sustained impact on all 4 scales of the Fecal Incontinence Quality of Life questionnaire (P < 0.001), Fecal Incontinence Severity Index scores improved from a mean of 39.9 to 28 (P < 0.001), and self-rated bowel health scores improved from a mean of 3.5 to 6.9 (P < 0.001).
Sacral nerve stimulation not only restores or improves continence in treated patients with chronic FI but also improves their quality of life and symptom severity.
After rigorous patient selection, sacral neurostimulation restores fecal continence and markedly enhances quality of life for at least four years.
From the *Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Fleurimont, Canada; †Medtronic, Inc, Minneapolis, MN; ‡Department of Colorectal Surgery, Cleveland Clinic, Florida, FL; §Division of Colon & Rectal Surgery, University of Minnesota, MN; ∥Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, MA; and ¶Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, OH.
Reprints: Ghislain Devroede, MD, MSc, Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke - Site Fleurimont, 3001, 12ème Ave N, Sherbrooke, Québec, Canada J1H 5N4. E-mail: firstname.lastname@example.org.
This article was orally presented at the American Urogynecologic Society Annual Meeting, Providence, RI; September 16, 2011.
Ghislain Devroede has received honoraria and research support from Medtronic. Dr Devroede has also conducted research in inflammatory bowel disease for the Millennium company. Anders 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), and Ethicon Endosurgery (research support, consultant). Steven D. 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. John Coller is coinvestigator on this current Medtronic-funded study. Robert Madoff is a consultant for Medtronic, Torax Medical, American Medical Systems, and Tsumara USA, Inc. Tracy Hull has received grant/research support from Medtronic, Cook Medical, and Oceana. Chad Giese, Katherine Stromberg, and Sudha Iyer are employees of Medtronic, Inc.