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
Lucas M Bachmann,
Armin Curt,
Patrick Freund,
Nikolai Pfender,
Martin Schubert,
Xavier Jordan,
Margret Hund-Georgiadis,
Veronika Birkhäuser,
Martina D Liechti,
Collene E Anderson,
Sarah Baumann,
Michael Baumberger,
Lori A Birder,
Sander M Botter,
Silvan Büeler,
Célia D Cruz,
Gergely David,
Susanne Friedl,
Oliver Gross,
Knut Husmann,
Miriam Koschorke,
Lorenz Leitner,
Eugenia Luca,
Ulrich Mehnert,
Sandra Möhr,
Freschta Mohammadzada,
Katia Monastyrskaya,
Helen Sadri,
Andrea M Sartori,
Kai Sprengel,
Stephanie A Stalder,
Jivko Stoyanov,
Cornelia Stress,
Aurora Tatu,
Cécile Tawadros,
Stéphanie van der Lely,
Jens Wöllner,
Veronika Zubler,
Jürgen Pannek,
Thomas M Kessler
Affiliations
Lucas M Bachmann
Medignition AG, Zurich, Switzerland
Armin Curt
Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland
Patrick Freund
Neurophysics, Max-Planck-Institut fur Kognitions- und Neurowissenschaften, Leipzig, Germany
Nikolai Pfender
Spinal Cord Injury Center, Balgrist University Hospital, University of Zurich, Zurich, Switzerland
Martin Schubert
Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland
Xavier Jordan
Spinal Cord Unit, Clinique romande de réadaptation, Sion, Switzerland
Margret Hund-Georgiadis
Clinic for neurorehabilitation and paraplegiology, REHAB Basel, Basel, Switzerland
Veronika Birkhäuser
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Martina D Liechti
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Collene E Anderson
Swiss Paraplegic Research, Nottwil, Switzerland
Sarah Baumann
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Michael Baumberger
Spinal Cord and Rehabilitation Medicine, Swiss Paraplegic Centre, Nottwil, Switzerland
Lori A Birder
Neuro-Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA
Sander M Botter
Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland
Silvan Büeler
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Célia D Cruz
Instituto de Investigação e Inovação em Saúde, Translational Neuro-urology Group, Universidade do Porto, Porto, Portugal
Gergely David
Spinal Cord Injury Center, Balgrist University Hospital, University of Zurich, Zurich, Switzerland
Susanne Friedl
Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Oliver Gross
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Knut Husmann
Swiss Center for Musculoskeletal Biobanking, Balgrist Campus AG, Zürich, Switzerland
Miriam Koschorke
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Lorenz Leitner
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Eugenia Luca
Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland
Ulrich Mehnert
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Sandra Möhr
Clinic of Neurorehabilitation and Paraplegiology, REHAB Basel, Basel, Switzerland
Freschta Mohammadzada
Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Katia Monastyrskaya
Urology Research Laboratory, DBMR, University of Bern, Bern, Switzerland
Helen Sadri
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Andrea M Sartori
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Kai Sprengel
Department of Trauma, University Hospital Zurich, Zurich, Switzerland
Stephanie A Stalder
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Jivko Stoyanov
Swiss Paraplegic Research, Nottwil, Switzerland
Cornelia Stress
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Aurora Tatu
Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland
Cécile Tawadros
Spinal Cord Injury Department, Clinique romande de réadaptation, Sion, Switzerland
Stéphanie van der Lely
Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
Jens Wöllner
Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland
Veronika Zubler
Department of Radiology, Balgrist University Hospital, Zürich, Switzerland
Jürgen Pannek
Neuro-Urology, Swiss Paraplegic Centre, Nottwil, Switzerland
Thomas M Kessler
Department of Neuro-Urology, Balgrist University Hospital, Zurich, Switzerland
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.
