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

Wexner, Steven D. MD*; Coller, John A. MD†; Devroede, Ghislain MD‡; Hull, Tracy MD§; McCallum, Richard MD¶; Chan, Miranda MD∥; Ayscue, Jennifer M. MD**; Shobeiri, Abbas S. MD††; Margolin, David MD‡‡; England, Michael MD§§; Kaufman, Howard MD¶¶; Snape, William J. MD∥∥; Mutlu, Ece MD***; Chua, Heidi MD†††; Pettit, Paul MD†††; Nagle, Deborah MD‡‡‡; Madoff, Robert D. MD§§§; Lerew, Darin R. PhD¶¶¶; Mellgren, Anders MD, PhD∥∥∥

Annals of Surgery:
doi: 10.1097/SLA.0b013e3181cf8ed0
Original Articles
Abstract

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.

In Brief

The purpose of this study was to determine the safety and efficacy of SNS in a large population under the rigors of an FDA-approved investigational protocol. 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 FI duration of 6.8 years, received chronic implantation. Sacral nerve stimulation using IterStim Therapy is a safe and effective treatment for patients with FI.

Author Information

From the *Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale, FL; †Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, MA; ‡Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Fleurimont, Canada; §Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, OH; ¶University of Kansas Medical Center, Kansas City, KS; ∥Colorectal Unit, Department of Surgery, Caritas Medical Centre, Hong Kong SAR, China; **Washington Hospital Center, Washington, DC; ††Center for Research in Women's Health, University of Oklahoma, Oklahoma City, OK; ‡‡Department of Colon and Rectal Surgery, The Ochsner Clinic Foundation, New Orleans, LA; §§Norman F. Gant Research Foundation, Forth Worth, TX; ¶¶Division of Colorectal Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA; ∥∥California Pacific Medical Center (CPMC), San Francisco, CA; ***Rush-Presbyterian-St. Luke's Medical Center (Rush University Medical Center), Chicago, IL; †††Clinical Studies Unit, Mayo Clinic, Jacksonville, FL; ‡‡‡Colon and Rectal Surgical Division, Beth Israel Deaconess Medical Center, Boston, MA; §§§Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, MN; ¶¶¶Medtronic Inc., Minneapolis, MN; and ∥∥∥Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, MN.

Presented at the annual meeting of the American Society of Colon and Rectal Surgeons in Hollywood FL, May 2–7, 2009.

Drs. 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. Dr. Wexner is also a consultant for Adolor/Glaxco Smith Kline, century Medical (Japan), EZ Surgical (Israel), Karl Storz Endoscopy, LifeCell, Neatstitch (Isreal), Niti (Israel), and Signalomics (Germany). He has stock options in EZ Surgical, Intuitive Surgical, Neatstitch, and SurgRx. He has the right to inventors' share income from Advanced Surgical Innovations, Covidien, Karl Storz Endoscopy, Unique Surgical Innovations. John Coller is co-investigator on this current Medtronic funded study. 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). Richard McCallum: Salix Pharmaceuticals, Inc: Self: Consulting fee: Advisory Committees or Review Panels; SmartPill Corporation: Self: Consulting fee: Advisory Committees or Review Panels; Takeda Pharmaceutical Company Ltd: Speaking and Teaching. Tracy Hull: Cook: Grant/Research Support; Medtronic. David Margolin: Surg RX: Self: Consulting fee: Speaking and Teaching. Howard Kaufman: Genzyme Biosurgery: Self: Consulting fee: Consulting; Genzyme Biosurgery: Self: Consulting fee: Speaking and Teaching; Medtronic Gastroenterology & Urology: Grant/Research Support; Synoyis Surgical: Self: Consulting fee: Advisory Committees or Review Panels; Synoyis Surgical: Grant/Research Support; Covidien: Self: Consulting fee: Consulting;Merck & Co: Self: Consulting fee: Speaking and Teaching. Darin R. Lerew; Employee, Medtronic, Inc. William Snape: Novartis Pharmaceuticals; Speaking and Teaching; Sucampo Pharmaceuticals; Speaking and Teaching; TAP Pharmaceutical; Takeda Pharmaceutical. Ece Mutlu: Abbott: Self: Consulting fee: Advisory Committees or Review Panels; Elan Pharmaceuticals, Inc: Self: Consulting fee: Advisory Committees or Review Panels; Salix Pharmaceuticals, Inc: Self: Consulting fee: Advisory Committees or Review Panels; Centocor, Inc: Self: Consulting fee: Advisory Committees or Review Panels; UCB, Inc: Self: Consulting fee: Advisory Committees or Review Panels. Robert Madoff is a consultant for Medtronic. All other authors have no financial disclosures to be acknowledged. This manuscript is dedicated to the memory of Dr. Joseph Tjandra.

Reprints: Steven D. Wexner, MD, Dept. of Colorectal Surgery, Cleveland Clinic FL, 2950 Cleveland Clinic Blvd., Fort Lauderdale, FL 33331. E-mail: wexners@ccf.org.

© 2010 Lippincott Williams & Wilkins, Inc.