Sacral Nerve Stimulation for Fecal Incontinence Results of a 120-Patient Prospective Multicenter Study

被引:228
作者
Wexner, Steven D. [1 ]
Coller, John A. [2 ]
Devroede, Ghislain [3 ]
Hull, Tracy [4 ]
McCallum, Richard [5 ]
Chan, Miranda [6 ]
Ayscue, Jennifer M. [7 ]
Shobeiri, Abbas S. [8 ]
Margolin, David [9 ]
England, Michael [10 ]
Kaufman, Howard [11 ]
Snape, William J. [12 ]
Mutlu, Ece [13 ]
Chua, Heidi [14 ]
Pettit, Paul [14 ]
Nagle, Deborah [15 ]
Madoff, Robert D. [16 ]
Lerew, Darin R. [17 ]
Mellgren, Anders [16 ]
机构
[1] Cleveland Clin FL, Dept Colorectal Surg, Ft Lauderdale, FL 33331 USA
[2] Lahey Clin Fdn, Dept Colon & Rectal Surg, Burlington, MA USA
[3] CHU Sherbrooke, Dept Surg, Fleurimont, PQ, Canada
[4] Cleveland Clin Fdn, Dept Colorectal Surg, Cleveland, OH 44195 USA
[5] Univ Kansas, Med Ctr, Kansas City, KS 66103 USA
[6] Caritas Med Ctr, Dept Surg, Colorectal Unit, Hong Kong, Hong Kong, Peoples R China
[7] Washington Hosp Ctr, Washington, DC 20010 USA
[8] Univ Oklahoma, Ctr Res Womens Hlth, Oklahoma City, OK USA
[9] Ochsner Clin Fdn, Dept Colon & Rectal Surg, New Orleans, LA USA
[10] Norman F Gant Res Fdn, Ft Worth, TX USA
[11] Univ So Calif, Keck Sch Med, Div Colorectal Surg, Los Angeles, CA 90033 USA
[12] Calif Pacific Med Ctr, San Francisco, CA USA
[13] Rush Univ, Rush Presbyterian St Lukes Med Ctr, Med Ctr, Chicago, IL 60612 USA
[14] Mayo Clin, Clin Studies Unit, Jacksonville, FL 32224 USA
[15] Beth Israel Deaconess Med Ctr, Colon & Rectal Surg Div, Boston, MA 02215 USA
[16] Univ Minnesota, Div Colon & Rectal Surg, Minneapolis, MN USA
[17] Medtronic Inc, Minneapolis, MN USA
关键词
ARTIFICIAL BOWEL SPHINCTER; SEVERE ANAL INCONTINENCE; DOUBLE-BLIND CROSSOVER; ELECTRICAL-STIMULATION; URINARY-INCONTINENCE; ECONOMIC-EVALUATION; OBSTETRIC INJURY; ONE INSTITUTION; SINGLE-CENTER; RISK-FACTORS;
D O I
10.1097/SLA.0b013e3181cf8ed0
中图分类号
R61 [外科手术学];
学科分类号
摘要
Background: Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods: Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing >= 50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that >= 50% of subjects would achieve therapeutic success, defined as >= 50% reduction of incontinent episodes per week at 12 months compared with baseline. Results: A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2-69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%-90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion: Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.
引用
收藏
页码:441 / 449
页数:9
相关论文
共 78 条
[1]   Permanent sacral nerve modulation for fecal incontinence and associated urinary disturbances [J].
Altomare, DF ;
Rinaldi, M ;
Petrolino, M ;
Monitillo, V ;
Sallustio, P ;
Veglia, A ;
De Fazio, M ;
Guglielmi, A ;
Memeo, V .
INTERNATIONAL JOURNAL OF COLORECTAL DISEASE, 2004, 19 (03) :203-209
[2]   Long-Term Outcome of Sacral Nerve Stimulation for Fecal Incontinence [J].
Altomare, Donato F. ;
Ratto, Carlo ;
Ganio, Ezio ;
Lolli, Paola ;
Masin, Alessandra ;
Villani, Roberto D. .
DISEASES OF THE COLON & RECTUM, 2009, 52 (01) :11-17
[3]   Safety and efficacy of dynamic graciloplasty for fecal incontinence -: Report of a prospective, multicenter trial [J].
Baeten, GMI ;
Bailey, HR ;
Bakka, A ;
Belliveau, P ;
Berg, E ;
Buie, WD ;
Burnstein, MJ ;
Christiansen, J ;
Coller, JA ;
Galandiuk, S ;
LaFontaine, LJ ;
Lange, J ;
Madoff, RD ;
Matzel, KE ;
Påhlman, L ;
Parc, R ;
Reilly, JC ;
Seccia, M ;
Thorson, AG ;
Vernava, AM ;
Wexner, S .
DISEASES OF THE COLON & RECTUM, 2000, 43 (06) :743-751
[4]  
Beck D. E., 1998, FUNDAMENTALS ANORECT
[5]   Neosphincter surgery for fecal incontinence:: A critical and unbiased review of the relevant literature [J].
Belyaev, O ;
Müller, C ;
Uhl, W .
SURGERY TODAY, 2006, 36 (04) :295-303
[6]  
BORRIE MJ, 1992, CAN MED ASSOC J, V147, P322
[7]   Sacral nerve stimulation for fecal incontinence:: External anal sphincter defect vs. intact anal sphincter [J].
Chan, Miranda K. Y. ;
Tjandra, Joe J. .
DISEASES OF THE COLON & RECTUM, 2008, 51 (07) :1015-1024
[8]  
Cheetham M., 2003, COCHRANE DB SYST REV
[9]   Observational Versus Experimental Studies: What's the Evidence for a Hierarchy? [J].
Concato J. .
NeuroRX, 2004, 1 (3) :341-347
[10]   Economic evaluation of sacral nerve stimulation for faecal incontinence [J].
Dudding, T. C. ;
Lee, E. Meng ;
Faiz, O. ;
Pares, D. ;
Vaizey, C. J. ;
McGuire, A. ;
Kamm, M. A. .
BRITISH JOURNAL OF SURGERY, 2008, 95 (09) :1155-1163