BTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract.

Abstract

Neurogenic lower urinary tract dysfunction (NLUTD) can lead to urinary urgency with or without incontinence and voiding dysfunction. Conservative therapies often fail and more invasive treatments (onabotulinumtoxinA injections, bladder augmentation, urinary diversion) have to be considered. Neuromodulation therapies such as transcutaneous tibial nerve stimulation (TTNS) are highly promising alternative treatment options. This paper presents the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of TTNS for refractory NLUTD. bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction (bTUNED) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is the success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the self-assessment goal achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures as well as the safety of TTNS. 240 patients with refractory NLUTD will be included and randomised 1:1 into the verum or sham TTNS group from 03/2020 until 08/2026. TTNS will be performed twice a week for 30 minutes during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.