BACKGROUND: Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence.
OBJECTIVES: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed.
DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation.
PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected.
INTERVENTIONS: Patients with ≥50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy.
MAIN OUTCOME MEASURES: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected.
RESULTS: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant.
CONCLUSIONS: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
1 Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio
2 Medtronic, Inc., Minneapolis, Minnesota
3 Department of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida
4 Division of Colon & Rectal Surgery, University of Minnesota, Minneapolis, Minnesota
5 Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Fleurimont, Quebec, Canada
6 Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, Massachusetts
Financial Disclosures: Dr Hull has received grant/research support from Medtronic, Cook Medical, and Oceana. Dr Wexner is a consultant in the field of fecal incontinence for Incontinent Devices Corp, Mederi Therapeutics, Salix, and after the conclusion and presentation of this study by Medtronic. In the field of fecal incontinence, Dr Mellgren has received honoraria and research support from Medtronic, American Medical Systems, Q-Med Scandinavia/Salix, and Uroplasty. Dr Coller is coinvestigator on this Medtronic-sponsored study. Dr Devroede has received honoraria and research support from Medtronic and has also conducted research in IBD for the Millenium company. Dr Madoff is a consultant for Medtronic, Torax Medical, American Medical Systems, and Tsumara USA Inc. Chad Giese and Katherine Stromberg are employees of Medtronic, Inc.
Podium presentation at the meeting of The American Society of Colon and Rectal Surgeons, San Antonio, TX, June 2 to 6, 2012.
Correspondence: Tracy Hull, M.D., The Cleveland Clinic Foundation, 9500 Euclid Ave, A30 DDI, Cleveland, OH 44195. E-mail: email@example.com