The Journal of Urology
Volume 183, Issue 4 , Pages 1438-1443 , April 2010

Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial

  • Kenneth M. Peters

      Affiliations

    • Beaumont Hospital, Royal Oak, Michigan
    • Corresponding Author InformationCorrespondence: Department of Urology, Beaumont Royal Oak, 3535 W. 13 Mile Rd., Suite 438, Royal Oak, Michigan 48073 (telephone: 248-551-0387; FAX: 248-551-8107)
    • Financial interest and/or other relationship with Medtronic and Uroplasty.
    • ,
  • Donna J. Carrico

      Affiliations

    • Beaumont Hospital, Royal Oak, Michigan
    • ,
  • Ramon A. Perez-Marrero

      Affiliations

    • Advanced Research Institute, Trinity, Florida
    • Financial interest and/or other relationship with Solvay, GSK and Novartis.
    • ,
  • Ansar U. Khan

      Affiliations

    • Urology Health Center, Fremont, Nebraska
    • ,
  • Leslie S. Wooldridge

      Affiliations

    • Mercy Health Partners, Muskegon, Michigan
    • Financial interest and/or other relationship with Uroplasty, Astellas and Watson.
    • ,
  • Gregory L. Davis

      Affiliations

    • Chico, California
    • Financial interest and/or other relationship with Ortho Women's Health and Urology Speaker Bureau.
    • ,
  • Scott A. MacDiarmid

      Affiliations

    • Alliance Urology Specialists, Greensboro, North Carolina
    • Financial interest and/or other relationship with Astellas, Allergan, Pfizer, Watson and Uroplasty.

Received 20 August 2009

References 

  1. Coyne KS, Payne C, Bhattacharyya SK, et al. The impact of urinary urgency and frequency on health-related quality of life in overactive bladder: results from a national community survey. Value Health. 2004;7:455
  2. Tyagi S, Thomas CA, Hayashi Y, et al. The overactive bladder: epidemiology and morbidity. Urol Clin North Am. 2006;33:433
  3. Teleman PM, Lidfeldt J, Nerbrand C, et al. Overactive bladder: prevalence, risk factors and relation to stress incontinence in middle-aged women. BJOG. 2004;111:600
  4. Dmochowski RR, Newman DK. Impact of overactive bladder on women in the United States: results of a national survey. Curr Med Res Opin. 2007;23:65
  5. Peters KM, Feber KM, Bennett RC. Sacral versus pudendal nerve stimulation for voiding dysfunction: a prospective, single-blinded, randomized, crossover trial. Neurourol Urodyn. 2005;24:643
  6. van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007;178:2029
  7. Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the Overactive Bladder Innovative Therapy Trial. J Urol. 2009;182:1055
  8. Cooperberg MR, Stoller ML. Percutaneous neuromodulation. Urol Clin North Am. 2005;32:71
  9. Finazzi Agro E, Campagna A, Sciobica F. Posterior tibial nerve stimulation: is the once-a-week protocol the best option?. Minerva Urol Nefrol. 2005;57:119
  10. van der Pal F, van Balken M and Heesakkers JP: Intensive percutaneous tibial nerve stimulation in the treatment of urge urinary incontinence does not increase the success rate. Presented at the joint meeting of the International Continence Society/International Urogynecological Association, Paris, France, August 25–27, 2004.
  11. Govier FE, Litwiller S, Nitti V, et al. Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. J Urol. 2001;165:1193
  12. van Balken MR, Vandoninck V, Gisolf KW, et al. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol. 2001;166:914
  13. Vandoninck V, van Balken MR, Finazzi Agro E, et al. Percutaneous tibial nerve stimulation in the treatment of overactive bladder: urodynamic data. Neurourol Urodyn. 2003;22:227
  14. Vandoninck V, van Balken MR, Finazzi Agro E, et al. Posterior tibial nerve stimulation in the treatment of urge incontinence. Neurourol Urodyn. 2003;22:17
  15. Vandoninck V, van Balken MR, Finazzi Agro E, et al. Posterior tibial nerve stimulation in the treatment of idiopathic nonobstructive voiding dysfunction. Urology. 2003;61:567
  16. van Leeuwen JH, Castro R, Busse M, et al. The placebo effect in the pharmacologic treatment of patients with lower urinary tract symptoms. Eur Urol. 2006;50:440
  17. Chapple C, van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52:1204
  18. Hassouna MM, Siegel SW, Nyeholt AA, et al. Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety. J Urol. 2000;163:1849
  19. Peters KM, Carrico DJ, Burks F. Validation of a sham for percutaneous tibial nerve stimulation (PTNS). Neurourol Urodyn. 2009;28:58
  20. Peters KM, Killinger KA, Ibrahim IA, et al. The relationship between subjective and objective assessments of sacral neuromodulation effectiveness in patients with urgency-frequency. Neurourol Urodyn. 2008;27:775
  21. Coyne KS, Matza LS, Thompson CL. The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Qual Life Res. 2005;14:849
  22. Ware JE, Snow KK, Kosinski M. SF-36® Health Survey: Manual and Interpretation Guide. Lincoln, Rhode Island: Quality Metrics Incorporated; 1996;
  23. Urgent® PC Instructions for Use (package insert). Minnetonka, Minnesota: Uroplasty, Inc; 2006;
  24. MacDiarmid SA, Peters KM, Shobeiri SA, et al. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. J Urol. 2010;183:234

 Study received institutional review board approval.

 Supported by Uroplasty, Inc.

 See Editorial on page 1282.

PII: S0022-5347(09)03200-5

doi: 10.1016/j.juro.2009.12.036

The Journal of Urology
Volume 183, Issue 4 , Pages 1438-1443 , April 2010

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