Beyond the Abstract - Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: A randomized, double-blind, placebo controlled trial, by Enrico Finazzi-Agrò, MD

BERKELEY, CA ( - Percutaneous tibial nerve stimulation (PTNS) has been in use clinically for more than 10 years

since Stoller first wrote about it in 1999,(1) and before randomized controlled studies confirmed its efficacy. Subsequently in 2009 and 2010, two papers from Peters and co-authors(2,3) produced evidence that PTNS is more effective than sham treatment and as effective as tolterodine extended release for the treatment of overactive bladder syndrome (OAB).

Our paper entitled “Percutaneous Tibial Nerve Stimulation Effects on Detrusor Overactivity Incontinence Are Not Due to a Placebo Effect: A Randomized Double-blind Placebo-controlled Trial” confirms the Peters’, et al. findings - a “placebo” effect is not the reason that PTNS improves urinary symptoms. Nevertheless, our results are somewhat different from those previously published. In our series, no patient in the placebo arm was considered a “responder,” defined as a reduction >50% of urge incontinence episodes. This excluded patients reporting some minor improvements of their general condition.

It is worthy to note that PTNS seems to produce effects on the central nervous system (CNS), similar to what has been observed during sacral nerve stimulation. In a previous paper,(4) we were able to demonstrate modifications in long latency somatosensory evoked potentials after PTNS. This study also showed that PTNS has a long-lasting effect on the CNS, during at least 24 hours after the stimulation session.

In conclusion, we believe that, after the publication of Peters’ papers and of our paper, the level of evidence of PTNS efficacy, and thus the argument for the use of PTNS for OAB treatment, will be more persuasive. We believe it could be possible in clinical practice to use PTNS earlier in the therapeutic algorithm, even in combination with drugs and other conservative treatments.


  1. Stoller ML: Afferent nerve stimulation for pelvic floor dysfunction. Eur Urol 1999;35(suppl 2):132.
  2. Peters KM, Carrico DJ, Perez-Marrero RA et al.: Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. J Urol. 2010 Apr;183(4):1438-43.
  3. 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 182(3):1055-61. 2009
  4. Finazzi Agrò E, Rocchi C, Pachatz C, Petta F, Spera E, Mori F, Sciobica F, Marfia GA: Percutaneous tibial nerve stimulation produces effects on brain activity: study on the modifications of the long latency somatosensory evoked potentials. Neurourol Urodyn. 2009;28(4):320-4.

Written by:
Enrico Finazzi-Agrò, MD as part of Beyond the Abstract on This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.

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