Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence

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 t...

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Veröffentlicht in:Diseases of the colon & rectum 2013-02, Vol.56 (2), p.234-245
Hauptverfasser: Hull, Tracy, Giese, Chad, Wexner, Steven D, Mellgren, Anders, Devroede, Ghislain, Madoff, Robert D, Stromberg, Katherine, Coller, John A
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container_end_page 245
container_issue 2
container_start_page 234
container_title Diseases of the colon & rectum
container_volume 56
creator Hull, Tracy
Giese, Chad
Wexner, Steven D
Mellgren, Anders
Devroede, Ghislain
Madoff, Robert D
Stromberg, Katherine
Coller, John A
description 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.
doi_str_mv 10.1097/DCR.0b013e318276b24c
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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 &lt; 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 &lt; 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.</description><identifier>ISSN: 0012-3706</identifier><identifier>EISSN: 1530-0358</identifier><identifier>DOI: 10.1097/DCR.0b013e318276b24c</identifier><identifier>PMID: 23303153</identifier><identifier>CODEN: DICRAG</identifier><language>eng</language><publisher>Hagerstown, MDc: The ASCRS</publisher><subject>Anal Canal - innervation ; Biological and medical sciences ; Chronic Disease ; Electric Stimulation Therapy - instrumentation ; Electric Stimulation Therapy - methods ; Electrodes, Implanted ; Fecal Incontinence - therapy ; Female ; Follow-Up Studies ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Male ; Medical sciences ; Other diseases. Semiology ; Quality of Life ; Sacrum - innervation ; Stomach. Duodenum. Small intestine. Colon. Rectum. 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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 &lt; 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 &lt; 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. 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Anus</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hull, Tracy</creatorcontrib><creatorcontrib>Giese, Chad</creatorcontrib><creatorcontrib>Wexner, Steven D</creatorcontrib><creatorcontrib>Mellgren, Anders</creatorcontrib><creatorcontrib>Devroede, Ghislain</creatorcontrib><creatorcontrib>Madoff, Robert D</creatorcontrib><creatorcontrib>Stromberg, Katherine</creatorcontrib><creatorcontrib>Coller, John A</creatorcontrib><creatorcontrib>SNS Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Diseases of the colon &amp; rectum</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hull, Tracy</au><au>Giese, Chad</au><au>Wexner, Steven D</au><au>Mellgren, Anders</au><au>Devroede, Ghislain</au><au>Madoff, Robert D</au><au>Stromberg, Katherine</au><au>Coller, John A</au><aucorp>SNS Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence</atitle><jtitle>Diseases of the colon &amp; rectum</jtitle><addtitle>Dis Colon Rectum</addtitle><date>2013-02</date><risdate>2013</risdate><volume>56</volume><issue>2</issue><spage>234</spage><epage>245</epage><pages>234-245</pages><issn>0012-3706</issn><eissn>1530-0358</eissn><coden>DICRAG</coden><abstract>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 &lt; 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 &lt; 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.</abstract><cop>Hagerstown, MDc</cop><pub>The ASCRS</pub><pmid>23303153</pmid><doi>10.1097/DCR.0b013e318276b24c</doi><tpages>12</tpages></addata></record>
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subjects Anal Canal - innervation
Biological and medical sciences
Chronic Disease
Electric Stimulation Therapy - instrumentation
Electric Stimulation Therapy - methods
Electrodes, Implanted
Fecal Incontinence - therapy
Female
Follow-Up Studies
Gastroenterology. Liver. Pancreas. Abdomen
Humans
Male
Medical sciences
Other diseases. Semiology
Quality of Life
Sacrum - innervation
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Surveys and Questionnaires
Treatment Outcome
title Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence
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