Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: A randomized, double-blind, placebo controlled trial

Enrico Finazzi-Agr, Filomena Petta, Francesco Sciobica, Patrizio Pasqualetti, Stefania Musco, Pierluigi Bove

Research output: Contribution to journalArticle


Purpose This is a prospective, double-blind, placebo controlled study, based on an original placebo technique, performed to evaluate the efficacy of percutaneous tibial nerve stimulation in female patients with detrusor overactivity incontinence. Materials and Methods A total of 35 female patients presenting with detrusor overactivity incontinence that did not respond to antimuscarinic therapy were randomly assigned to percutaneous tibial nerve stimulation or to a control group. The percutaneous tibial nerve stimulation group (18 patients) was treated with 12 percutaneous tibial nerve stimulation sessions. The control group (17 patients) received an original placebo treatment using a 34 gauge needle placed in the medial part of the gastrocnemius muscle. The sessions lasted for 30 minutes and were performed 3 times weekly as percutaneous tibial nerve stimulation sessions. All patients were evaluated with bladder diaries as well as quality of life scores before and after treatment. Patients showing a reduction in urge incontinence episodes greater than 50% were considered responders. Results Some patients (1 in the percutaneous tibial nerve stimulation group and 2 in the placebo group) did not complete the study for reasons not related to the technique. Of 17 patients in the percutaneous tibial nerve stimulation group 12 (71%) and of 15 in placebo group 0 were considered responders according to the previously reported definition (p

Original languageEnglish
Pages (from-to)2001-2006
Number of pages6
JournalJournal of Urology
Issue number5
Publication statusPublished - Nov 2010



  • Electric stimulation therapy
  • Placebos
  • Tibial nerve
  • Urinary incontinence

ASJC Scopus subject areas

  • Urology
  • Medicine(all)

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