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Infection Rates in a Large Investigational Trial of Sacral Nerve Stimulation for Fecal Incontinence

  • 2009 SSAT Plenary Presentation
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Introduction

Treatment options for patients with fecal incontinence (FI) are limited, and surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe. A large multicenter trial was conducted in North America and Australia to assess the efficacy of SNS in patients with chronic fecal incontinence. The aim of this report was to analyze the infectious complication rates in that trial.

Methods

Adult patients with a history of chronic fecal incontinence were enrolled into this study. Those patients who fulfilled study inclusion/exclusion criteria and demonstrated greater than two FI episodes per week underwent a 2-week test phase of SNS. Patients who showed a ≥50% reduction in incontinent episodes and/or days per week underwent chronic stimulator implantation. Adverse events were reported to the sponsor by investigators at each study site and then coded. All events coded as implant site infection were included in this analysis.

Results

One hundred twenty subjects (92% female, 60.5 ± 12.5 years old) received a chronically implanted InterStim® Therapy device (Medtronic, Minneapolis, MN, USA). Patients were followed for an average of 28 months (range 2.2-69.5). Thirteen of the 120 implanted subjects (10.8%) reported infection after the chronic system implant. One infection spontaneously resolved and five were successfully treated with antibiotics. Seven infections (5.8%) required surgical intervention, with infections in six patients requiring full permanent device explantation. The duration of the test stimulation implant procedure was similar between the infected group (74 min) and the non-infected group (74 min). The average duration of the chronic neurostimulator implant procedure was also similar between the infected (39 min) and non-infected group (37 min). Nine infections occurred within a month of chronic system implant and the remaining four infections occurred more than a year from implantation. While the majority (7/9) of the early infections was successfully treated with observation, antibiotics, or system replacement, all four of the late infections resulted in permanent system explantation.

Conclusion

SNS for FI resulted in a relatively low infection rate. This finding is especially important because the only other Food and Drug Administration-approved treatment for end-stage FI, the artificial bowel sphincter, reports a much higher rate. Combined with its published high therapeutic success rate, this treatment has a positive risk/benefit profile.

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Acknowledgments

The authors would like to thank Helen Berrier, Shufeng Liu, and Ingrid Winter for their dedicated work on this manuscript and the conduct of this study. In addition, we express our thanks to all of the study coordinators who made this study possible.

Author information

Authors and Affiliations

  1. Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale, FL, USA

    Steven D. Wexner & Yair Edden

  2. Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, MA, USA

    John A. Coller

  3. Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Fleurimont, Canada

    Ghislain Devroede

  4. Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, OH, USA

    Tracy Hull

  5. University of Kansas Medical Center, Kansas City, KS, USA

    Richard McCallum

  6. Colorectal Unit, Department of Surgery, Caritas Medical Centre, Hong Kong, China

    Miranda Chan

  7. Washington Hospital Center, Washington, DC, USA

    Jennifer M. Ayscue

  8. Center for Research in Women’s Health, University of Oklahoma, Oklahoma City, OK, USA

    Abbas S. Shobeiri

  9. Department of Colon and Rectal Surgery, The Ochsner Clinic Foundation, New Orleans, LA, USA

    David Margolin

  10. Norman F. Gant Research Foundation, Fort Worth, TX, USA

    Michael England

  11. Division of Colorectal Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

    Howard Kaufman

  12. Rush-Presbyterian-St. Luke’s Medical Center (Rush University Medical Center), Chicago, IL, USA

    William J. Snape & Ece Mutlu

  13. Clinical Studies Unit, Mayo Clinic, Jacksonville, FL, USA

    Heidi Chua & Paul Pettit

  14. Colon and Rectal Surgical Division, Beth Israel Deaconess Medical Center, Boston, MA, USA

    Deborah Nagle

  15. Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, MN, USA

    Robert D. Madoff & Anders Mellgren

  16. Medtronic Inc., Minneapolis, MN, USA

    Darin R. Lerew

Authors
  1. Steven D. Wexner
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  2. Tracy Hull
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  3. Yair Edden
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  7. Miranda Chan
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  11. Michael England
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  18. Robert D. Madoff
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  20. Anders Mellgren
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Corresponding author

Correspondence to Steven D. Wexner.

Additional information

Discussant

Dr. James Fleshman (St. Louis): I want to thank Dr. Wexner for providing me with the manuscript and the presentation prior to today.

I also want to congratulate Dr. Wexner and his colleagues on an excellent effort to finally bring a reliable method of treating almost all types of fecal incontinence to the United States. As Dr. Wexner mentioned, other methods of treatment of incontinence or sphincter replacement have been plagued by infection-related complications. The infection rate of 10.8% is actually very commendable.

I have several questions that I would like to ask Dr. Wexner regarding the study. The exclusion criteria of the study eliminated women of child-bearing potential, larger sphincter defects, and patients with failed, recent, anal sphincter repairs.

Number one, can we assume that these patients will be benefited and eventually considered candidates? Dr. Joe Chandra, before he died, showed that the mechanism of action is probably levator plate lift, and, therefore, should probably be successful even in patients with large sphincter defects.

Number two, the infection documentation was left to the investigator at each institution and there was no real definition. Could this have biased the result? And would a third-party evaluation or audit be better to define the infection rate?

Number three, the infection rates varied by institution and may have been affected by the lack of standardization, but can you give us an idea of the methods you would now propose to prevent infection? And could they include antibiotic impregnated leads, prophylactic long-term antibiotics, and staphaureous skin colony reduction?

Number four, what is the cost of explantation, both in terms of resource consumption or dollars, as well as psyche and detriment to defunction? Are these patients any worse for wear after this procedure?

Thank you very much for the opportunity to comment on this excellent study.

Closing discussant

Dr. Steve Wexner: Thanks very much, Dr. Fleshman. I very much appreciate you having taking the time to review the manuscript and to review the slides on short notice, I might add, and I am very appreciative of the insight you’ve given to us.

I’ll try to answer those couple of questions. First, in terms of the potential benefit to multiparous women who have had some sphincter injury, Joe Tjandra reported good success in patients with defects of up to 120 degrees. The study that I just reported included patients with defects of up to 60 degrees of whom I believe there were 13 out of 120 patients.

Although we can’t tell from this current study about the anticipated results with larger defects, Joe was an excellent investigator and much missed and certainly by his work it appears that up to 120 degrees is satisfactory and perhaps even more. The SNS may work by more of a pelvic bellows pulling up, plus some type of sensory augmentation through neuromodulation that we absolutely don’t yet understand.

So through the combination of a better early warning system, and better sensation and pelvic floor lifting, patients do seem to be able to gain some augmentation to their continence even if those patients have large defects. That issue will be worked out I’m sure, in this country, hopefully, once the device is FDA approved.

Second, in terms of infection, absolutely, that was one of the major limitations of the study. The definition was rather nebulous, and was individually determined at each site.

Having said that, I think the natural trepidation every surgeon has in implanting a foreign body anywhere near the anus, or spinal cord in this case, leads to assuming and treating infection at a very low threshold. And if anything, in this FDA scrutininzed data set, the investigators were probably overdiagnosing rather than underdiagnosing and therefore overtreating rather than undertreating, just because of the fear of a problem in the CNS with implantation of the stimulator.

Also, as you alluded to, if we look at infection rates for artificial bowel sphincter, 25% are explanted for infection. Stimulated graciloplasty infection rates were not that high, but that therapy is not available in this country anymore. That’s not the case here. In the current study six devices out of 120 were explanted due to infection. A much lower rate was observed than with other therapies using the most stringent objective, definable end point - explantation. So I absolutely agree with you, it was poorly defined at the beginning. There was a lack of standardization as you correctly mentioned.

To answer your third question, currently, I would use short-term prophylactic antibiotics, not long-term; which would include, as you mentioned, staph coverage. The leads are not impregnated with antibiotics, but I absolutely would soak them in antibiotics before implanting them. I would soak the device as well as long as you are not using something that’s going to corrode the actual device, but soak in antibiotics.

To answer your fourth and final question, in terms of the explantation, the study allowed a reimbursement of $6,000 per revision or explantation. So how your hospital comes in, relative to that $6,000, one would guess how much does it cost to bring a patient to the operating room, and explant the device, and treat them with parenteral antibiotics. It could be $6,000 but it could be $10,000. It is absolutely costly but, again, fortunately it is relatively rare. And yes, you are correct, it does have a major detrimental toll on patients’ psyche when this procedure fails because these patients don’t have much more to go to. They could consider an artificial bowel sphincter, or they could be looking at a Malone antegrade colonic enema procedure, or stoma, or in this country a nonstimulated graciloplasty. None of which are particularly palatable to many patients.

I recently explanted somebody, not for infection, but just because of efficacy failure. And she’s quite devastated by the loss of her stimulator even though her result was suboptimal. She was not one of the star pupils, still she was devastated. Patients feel they have lost hope for a relatively, noninvasive method compared to an ABS or graciloplasty and certainly compared to a stoma. Thanks again Dr Fleshman for your thoughtful insights and excellent questions.

Author disclosures

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 (Israel), 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.

ClinicalTrials.gov Identifier: NCT00200057

Sponsor: Medtronic, Inc.

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Wexner, S.D., Hull, T., Edden, Y. et al. Infection Rates in a Large Investigational Trial of Sacral Nerve Stimulation for Fecal Incontinence. J Gastrointest Surg 14, 1081–1089 (2010). https://doi.org/10.1007/s11605-010-1177-z

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  • DOI: https://doi.org/10.1007/s11605-010-1177-z

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