TASCI-transcutaneous tibial nerve stimulation in patients with acute spinal cord injury to prevent neurogenic detrusor overactivity: protocol for a nationwide, randomised, sham-controlled, double-blind clinical trial

Abstract

Introduction: Neurogenic lower urinary tract dysfunction (NLUTD), including neurogenic detrusor overactivity (NDO) and detrusor sphincter dyssynergia, is one of the most frequent and devastating sequelae of spinal cord injury (SCI), as it can lead to urinary incontinence and secondary damage such as renal failure. Transcutaneous tibial nerve stimulation (TTNS) is a promising, non-invasive neuromodulatory intervention that may prevent the emergence of the C-fibre evoked bladder reflexes that are thought to cause NDO. This paper presents the protocol for TTNS in acute SCI (TASCI), which will evaluate the efficacy of TTNS in preventing NDO. Furthermore, TASCI will provide insight into the mechanisms underlying TTNS, and the course of NLUTD development after SCI.

Methods and analysis: TASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial, conducted at all four SCI centres in Switzerland. The longitudinal design includes a baseline assessment period 5-39 days after acute SCI and follow-up assessments occurring 3, 6 and 12 months after SCI. A planned 114 participants will be randomised into verum or sham TTNS groups (1:1 ratio), stratified on study centre and lower extremity motor score. TTNS is performed for 30 min/day, 5 days/week, for 6-9 weeks starting within 40 days after SCI. The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation. Secondary outcome measures assess bladder and bowel function and symptoms, sexual function, neurological structure and function, functional independence, quality of life, as well as changes in biomarkers in the urine, blood, stool and bladder tissue. Safety of TTNS is the tertiary outcome.

Ethics and dissemination: TASCI is approved by the Swiss Ethics Committee for Northwest/Central Switzerland, the Swiss Ethics Committee Vaud and the Swiss Ethics Committee Zürich (#2019-00074). Findings will be disseminated through peer-reviewed publications.

Trial registration number: NCT03965299.

Keywords: bladder disorders; neuro-urology; neurological injury; rehabilitation medicine; urinary incontinences.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Trial flow chart. Safety data will be recorded on a continuous basis the entire time the participant is enrolled in the study. *Additional clinical assessments target urological and bowel function and symptoms, neurological structure and function, sexual function, spasticity, functional independence, quality of life and biochemical and molecular biomarkers in the urine, blood, stool and in bladder tissue (additional consent required for bladder biopsy). **Histomorphology is based on bladder biopsy which requires additional consent. DO, detrusor overactivity; SCI, spinal cord injury; TTNS, transcutaneous tibial nerve stimulation.

Figure 2

Transcutaneous tibial nerve stimulation (TTNS) intervention. Pictures of the TTNS device, cables and electrode placements. (A) The TTNS device has two channels that can be adjusted independently. Electrodes are placed in a specified, standardised order (1–4). (B) Lateral view of the foot, showing the electrode placement on the dorsal bone and plantar fat pad of the fifth metatarsophalangeal joint. (C) Medial view of the foot, electrodes are placed 4–5 cm proximal and posterior to the medial malleolus, as well as in the longitudinal arch of the foot, distal to, and in line with, the medial malleolus.