Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial

Abstract Background Transcutaneous tibial nerve stimulation (TTNS) and percutaneous (PTNS) are effective safe therapies for overactive bladder (OAB) syndrome in adults. However, few randomized sham-controlled trials have been conducted a pediatric population. To our knowledge, both never compared children. Aim The aim of the complete study is twofold: (1) to assess efficacy TTNS therapy on symptoms after 12 weeks treatment population with idiopathic (iOAB) and/or nocturnal enuresis (part I) (2) effect PTNS II). In this article, we present protocol first part TaPaS trial (TTNS, PTNS, sham therapy). Methods Part I set up as single-center randomized-controlled trial. Children, aged from 5 years iOAB enuresis, assigned two groups by computer-generated randomization: (intervention) (control). primary outcome percentage difference average voided volume (AVV) between baseline treatment. Secondary endpoints supervoid volumes, number urinary incontinence episodes/24 h voiding frequency, parent reported outcomes treatment, duration clinical response. Discussion We hypothesize that non-inferior children therapy. Since literature inconclusive about population, RCT will be I). A prospective has developed. Enrolment started November 2018. Study completion expected August 2021. Trial registration ClinicalTrials.gov NCT 04256876 . Retrospectively registered February 5, 2020.