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Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence.
MedLine Citation:
PMID:  23303153     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Tracy Hull; Chad Giese; Steven D Wexner; Anders Mellgren; Ghislain Devroede; Robert D Madoff; Katherine Stromberg; John A Coller;
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Publication Detail:
Type:  JOURNAL ARTICLE    
Journal Detail:
Title:  Diseases of the colon and rectum     Volume:  56     ISSN:  1530-0358     ISO Abbreviation:  Dis. Colon Rectum     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-1-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372764     Medline TA:  Dis Colon Rectum     Country:  -    
Other Details:
Languages:  ENG     Pagination:  234-245     Citation Subset:  -    
Affiliation:
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.
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