Clinical Studies Update – Neuro-urology Update from TASCI, a Nationwide, Randomized, Sham-controlled, Double-blind Clinical Trial on Transcutaneous Tibial Nerve Stimulation in Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity Martina D. Liechti a , Ste ´phanie van der Lely a , Stephanie A. Stalder a , Collene E. Anderson a,b,c , Veronika Birkha ¨user a , Lucas M. Bachmann d , Martin W.G. Brinkhof b,c , Armin Curt e , Xavier Jordan f , Lorenz Leitner a , Ulrich Mehnert a , Sandra Mo ¨hr g , Ju ¨rgen Pannek h,i , Martin Schubert e , Thomas M. Kessler a, *, for the TASCI Study Group a Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; b Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland; c Swiss Paraplegic Research, Nottwil, Switzerland; d Medignition Inc. Research Consultants, Zürich, Switzerland; e Neurology, Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; f Clinique Romande de Réadaptation, Sion, Switzerland; g Neuro-Urology, REHAB Basel, Basel, Switzerland; h Neuro-Urology, Swiss Paraplegic Center, Nottwil, Switzerland; i Department of Urology, Inselspital, Bern University Hospital, Bern, Switzerland 1. Background Most patients with a spinal cord injury (SCI) develop neu- rogenic lower urinary tract dysfunction (LUTD), one of the most devastating sequelae of SCI that ultimately can lead to renal failure [1,2]. Interventions that prevent neurogenic LUTD before irreversible damage occurs are urgently needed. Neuromodulation procedures are a promising ave- nue [3–7]. Therefore, we investigate the effect of transcuta- neous tibial nerve stimulation (TTNS) in the early phase after SCI. Setting up such a demanding multicentre study involves a thorough preparation. Here we provide an update on operational progress of this multicenter randomized controlled trial (RCT) investigating the efficacy of TTNS in patients with acute SCI to prevent neurogenic detrusor overactivity (DO) from jeopardizing the upper urinary tract. 2. Design, setting, and participants TASCI (Fig. 1) is a nationwide, randomized, sham-controlled, double-blind clinical trial that includes all SCI centers in Switzerland (Basel, Nottwil, Sion, and Zürich) and is nested in the Swiss Spinal Cord Injury cohort study (SwiSCI; www. swisci.ch). The power calculation for the trial indicated that 114 patients should be recruited. Detailed inclusion and exclu- sion criteria are listed on ClinicalTrials.gov (NCT03965299). Patients are randomly assigned to verum TTNS (active stimu- lation; n = 57) or sham stimulation (n = 57) in a 1:1 allocation using computer-generated permuted block randomization lists stratified by study center and lower extremity motor score. Screening and baseline assessments are performed between days 5 and 39 after cervical or thoracic SCI, while TTNS is started by day 40 at the latest. Follow-up assessments are conducted 3, 6, and 12 mo after SCI. All procedures have been approved by Swissethics (BASEC-Nr. 2019-00074). Monitoring and quality assurance will be carried out by the Unit for Clinical and Applied Research of Balgrist University Hospital. 3. Intervention Before each treatment phase (30 min) sensory and motor thresholds are assessed and stimulation intensities are adjusted. Intervention sessions are performed five times a E U R O P E A N U R O L O G Y F O C U S X X X ( 2 0 1 9 ) X X X – X X X ava ilable at www.sciencedirect.com journa l homepage: www.europea nurology.com/eufocus * Corresponding author. Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Forchstrasse 340, 8008 Zürich, Switzerland. Tel.: +41 44 3863907; Fax: +41 44 3863909. E-mail address: tkessler@gmx.ch (T.M. Kessler). EUF-811; No. of Pages 3 Please cite this article in press as: Liechti MD, et al. Update from TASCI, a Nationwide, Randomized, Sham-controlled, Double- blind Clinical Trial on Transcutaneous Tibial Nerve Stimulation in Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity. Eur Urol Focus (2019), https://doi.org/10.1016/j.euf.2019.09.019 https://doi.org/10.1016/j.euf.2019.09.019 2405-4569/© 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved.