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Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study

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Diseases of the Colon & Rectum

Abstract

Purpose

This randomized study was designed to compare the effect of sacral neuromodulation with optimal medical therapy in patients with severe fecal incontinence.

Methods

Patients (aged 39–86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation (SNS group; n = 60) or best supportive therapy (control; n = 60), which consisted of pelvic floor exercises, bulking agent, and dietary manipulation. Full assessment included endoanal ultrasound, anorectal physiology, two-week bowel diary, and fecal incontinence quality of life index. The follow-up duration was 12 months.

Results

The sacral nerve stimulation group was similar to the control group with regard to gender (F:M = 11:1 vs. 14:1) and age (mean, 63.9 vs. 63 years). The incidence of a defect of ≤ 120° of the external anal sphincter and pudendal neuropathy was similar between the groups. Trial screening improved incontinent episodes by more than 50 percent in 54 patients (90 percent). Full-stage sacral nerve stimulation was performed in 53 of these 54 “successful” patients. There were no septic complications. With sacral nerve stimulation, mean incontinent episodes per week decreased from 9.5 to 3.1 (P < 0.0001) and mean incontinent days per week from 3.3 to 1 (P < 0.0001). Perfect continence was accomplished in 25 patients (47.2 percent). In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group.

Conclusions

Sacral neuromodulation significantly improved the outcome in patients with severe fecal incontinence compared with the control group undergoing optimal medical therapy.

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References

  1. Nelson R, Norton N, Cautley F, Furner S. Community based prevalence of anal incontinence. JAMA 1995;274:559–61.

    Article  PubMed  CAS  Google Scholar 

  2. Campbell AJ, Reinken J, McCosh L. Incontinence in the elderly: prevalence and prognosis. Age Ageing 1985;14:65–70.

    Article  PubMed  CAS  Google Scholar 

  3. Roberts RO, Jacobsen SJ, Reilly WT, Pemberton JH, Lieber MM, Talley NJ. Prevalence of combined fecal and urinary incontinence: a community-based study. J Am Geriatr Soc 1999;47:837–41.

    PubMed  CAS  Google Scholar 

  4. Madoff RD, Williams JG, Caushaj PF. Fecal incontinence. N Engl J Med 1992;326:1002–7.

    Article  PubMed  CAS  Google Scholar 

  5. Tjandra JJ, Milsom JW, Schroeder T, Fazio V. Endoluminal ultrasound is preferable to electromyography in mapping anal sphincter defect. Dis Colon Rectum 1993;36:689–92.

    Article  PubMed  CAS  Google Scholar 

  6. Tan JJ, Chan MK, Tjandra JJ. Evolving therapy for fecal incontinence. Dis Colon Rectum 2007;50:1950–67.

    Article  PubMed  Google Scholar 

  7. Wong WD, Congliosi SM, Spencer MP, et al. The safety and efficacy of the artificial bowel sphincter for fecal incontinence: results from a multicenter cohort study. Dis Colon Rectum 2002;45:1139–53.

    Article  PubMed  Google Scholar 

  8. Wexner SD, Baeten C, Bailey R, et al. Safety and efficacy of dynamic graciloplasty for fecal incontinence: report of a prospective, multicenter trial. Dis Colon Rectum 2000;43:743–51.

    Article  PubMed  Google Scholar 

  9. Tjandra JJ, Lim JF, Matzel K. Sacral nerve stimulation - an emerging treatment for faecal incontinence. ANZ J Surg 2004;74:1098–106.

    Article  PubMed  Google Scholar 

  10. Matzel KE, Kamm MA, Stosser M, et al. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet 2004;363:1270–6.

    Article  PubMed  Google Scholar 

  11. Hetzer FH, Hahnloser D, Clavien P-A, Demartines N. Quality of life and morbidity after permanent sacral nerve stimulation for fecal incontinence. Arch Surg 2007;142:8–13.

    Article  PubMed  Google Scholar 

  12. Kenefick NJ, Nicholls RJ, Cohen RG, Kamm MA. Medium-term results of permanent sacral nerve stimulation for faecal incontinence. Br J Surg 2002;89:896–901.

    Article  PubMed  CAS  Google Scholar 

  13. Gourcerol G, Gallas S, Michot F, Denis P, Leroi AM. Sacral nerve stimulation in fecal incontinence: are there factors associated with success. Dis Colon Rectum 2007;50:3–12.

    Article  PubMed  Google Scholar 

  14. Conaghan P, Farouk R. Sacral nerve stimulation can be successful in patients with ultrasound evidence of external anal sphincter disruption. Dis Colon Rectum 2005;48:1610–4.

    Article  PubMed  Google Scholar 

  15. Rosen HR, Urbarz C, Holzer B, Novi G, Schiessel R. Sacral nerve stimulation as a treatment for fecal incontinence. Gastroenterology 2001;121:536–41.

    Article  PubMed  CAS  Google Scholar 

  16. Tjandra JJ, Sharma BR, McKirdy H, Lowndes RH, Mansel RE. Anorectal physiological testing in defaecatory disorders: a prospective study. ANZ J Surg 1994;64:322–6.

    Article  CAS  Google Scholar 

  17. Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993;36:77–97.

    Article  PubMed  CAS  Google Scholar 

  18. Rockwood TH, Church JM, Fleshman JW et al. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000;43:9–16.

    Article  PubMed  CAS  Google Scholar 

  19. Ware JE, Kosinski M, Keller SD. SF-12: How to score the SF-12 Physical and Mental Health Summary Scales. Boston: The Health Institute, New England Medical Center, 1995.

    Google Scholar 

  20. Lowry AC, Simmang CL, Boulous P, et al. Consensus statement of definitions for anorectal physiology and rectal cancer. Colorectal Dis 2001;3:272–5.

    Article  PubMed  CAS  Google Scholar 

  21. Ooi BS, Tjandra JJ, Tang CL, Dwyer P, Carey M. Anorectal physiological testing before and after a successful sphincter repair: a prospective study. Colorectal Dis 2000;2:220–8.

    Article  Google Scholar 

  22. Leroi AM, Parc Y, Lehur PA, et al. Efficacy of sacral nerve stimulation for fecal incontinence. Results of a multicenter double-blind crossover study. Ann Surg 2005;242:662–9.

    Article  PubMed  Google Scholar 

  23. Rothbarth J, Bemelman WA, Meijerink WJ. What is the impact of fecal incontinence on quality of life? Dis Colon Rectum 2001;44:67–71.

    Article  PubMed  CAS  Google Scholar 

  24. Tjandra JJ, Lim JF, Hiscock R, Rajendra P. Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective. Dis Colon Rectum 2004;47:2138–46.

    Article  PubMed  CAS  Google Scholar 

  25. Melenhorst J, Koch SM, Uludag O, van Gemert WG, Baeten CG. Sacral nerve modulation for faecal incontinence: repaired anal sphincter complex versus anal sphincter defect. Colorectal Dis 2006;8(4):1–2.

    Article  Google Scholar 

  26. Altomare D, Rinaldi M, Petrolino M, et al. Permanent sacral nerve modulation for faecal incontinence and associated urinary disturbances. Int J Colorectal Dis 2004;19:203–20.

    Article  PubMed  Google Scholar 

  27. Leroi AM, Michot F, Grise P, Denis P. Effect of sacral nerve stimulation in patients with faecal and urinary incontinence. Dis Colon Rectum 2001;44:779–89.

    Article  PubMed  CAS  Google Scholar 

  28. Ganio E, Masin A, Ratto C, et al. Short-term sacral nerve stimulation for functional anorectal and urinary disturbances: results in 40 patients: evaluation of a new option for anorectal functional disorders. Dis Colon Rectum 2001;44:1261–7.

    Article  PubMed  CAS  Google Scholar 

  29. Matzel K, Bittorf B, Stadelmaier U, Hohenfellner M, Hohenberger W. Sakralnervstimulation in der Behandlung der Stuhlinkontinenz. Chirurg 2003;74:26–32.

    Article  PubMed  CAS  Google Scholar 

  30. Schurch B, Reilly I, Reitz A, Curt A. Electrophysiological recordings during the peripheral nerve evaluation (PNE) test in complete spinal cord injury patients. World J Urol 2003;20:319–22.

    PubMed  CAS  Google Scholar 

  31. Matzel KE, Stadelmaier U, Gall FP. Direct electrostimulation of the sacral spinal nerves in diagnosis of anorectal function. Lang Arch Chirurgie 1995;380:184–8.

    CAS  Google Scholar 

  32. Matzel KE, Stadelmaier U, Hohenfellneer M, Gall FP. Electrical stimulation for the treatment of fecal incontinence. Lancet 1995;346:1124–7.

    Article  PubMed  CAS  Google Scholar 

  33. HiJaz A, Vasavada SP, Daneshgari F, Frinjari H, Goldman H, Rackley R. Complications and troubleshooting of two-stage sacral neuromodulation therapy: a single-institution experience. Urology 2006;68:533–7.

    Article  PubMed  Google Scholar 

  34. Byrne CM, Solomon MJ, Young JM, Rex J, Merlino CL. Biofeedback for fecal incontinence: short-term outcomes of 513 consecutive patients and predictors of successful treatment. Dis Colon Rectum 2007;50:417–27.

    Article  PubMed  Google Scholar 

  35. Hetzer FH, Bieler A, Hahnloser D, Lohlein F, Clavien P-A, Demartines N. Outcome and cost analysis of sacral nerve stimulation for faecal incontinence. Br J Surg 2006;93:1411–7.

    Article  PubMed  CAS  Google Scholar 

Download references

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Correspondence to Miranda K. Y. Chan M.B.B.S., F.R.A.C.S..

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*Deceased.

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Tjandra*, J.J., Chan, M.K.Y., Yeh, C.H. et al. Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study. Dis Colon Rectum 51, 494–502 (2008). https://doi.org/10.1007/s10350-007-9103-5

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  • DOI: https://doi.org/10.1007/s10350-007-9103-5

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