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

Liechti, Martina D.; Lely, Stéphanie van der; Stalder, Stephanie A; Anderson, Collene E.; Birkhäuser, Veronika; Bachmann, Lucas M.; Brinkhof, Martin W. G.; Curt, Armin; Jordan, Xavier; Leitner, Lorenz; Mehnert, Ulrich; Möhr, Sandra; Pannek, Jürgen; Schubert, Martin; Kessler, Thomas M.

doi:10.1016/j.euf.2019.09.019

Cited by 6 publications

(6 citation statements)

References 7 publications

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“…As an adjunct to this review, it will be interesting to evaluate the results of the study proposed by a Swiss team 33 on SCI, which is currently underway. This randomized controlled trial has completed the preparatory phase, 33 but the final results could not be retrieved in the literature. Of note, this study emphasizes the need to assess motor response before applying TTNS, as suggested by other authors for PTNS 34 .…”

Section: Discussionmentioning

confidence: 99%

“…Finally, the nurse should take a thorough medical and surgical history, investigate eat- on large cohorts of patients with comparable conditions, are also needed to define criteria for maintaining outcomes achieved through TNS. As an adjunct to this review, it will be interesting to evaluate the results of the study proposed by a Swiss team 33 on SCI, which is currently underway. This randomized controlled trial has completed the preparatory phase, 33 but the final results could not be retrieved in the literature.…”

Section: Study Interventionmentioning

confidence: 99%

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Clarifying practical aspects of posterior tibial nerve stimulation for neurogenic overactive bladder: A scoping review

Terzoni,

Ferrara,

Di Schiena

et al. 2024

Int J of Uro Nursing

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Patients with neurological diseases often suffer from overactive bladder. Posterior tibial nerve stimulation is mentioned in guidelines as a treatment when antimuscarinics fail or cannot be tolerated by patients, but the evidence is scant. This article summarizes the evidence on the practical aspects of tibial nerve stimulation for neurogenic overactive bladder (NOAB), such as electrical parameters and treatment duration, and identifies areas requiring further investigation. Scoping review. Literature search on PubMed, CINAHL, and Cochrane Library, including studies from 2010 to 2024 regarding tibial nerve stimulation for NOAB. Sixteen papers were considered: seven on transcutaneous tibial nerve stimulation (TTNS), seven on percutaneous tibial nerve stimulation (PTNS) and two protocols. Most studies enrolled neurological and non‐neurological patients or studied non‐randomized samples of a few patients. Clinical outcomes, treatment duration, number of sessions, and follow‐up times showed considerable heterogeneity, but some practical recommendations could be drawn. For PTNS, most authors suggest using 20 Hz and 200 μs, but the amplitude is highly variable among studies. For TTNS, 10 Hz and 200 μs are suggested, with considerable variability in the number of sessions and overall treatment duration. Most papers propose similar criteria regarding the frequency and duration of the stimulation, and all of them support the efficacy of tibial nerve stimulation, except for one. The areas requiring research include long‐term results, allowing for shaping adequate maintenance programmes to avoid losing the results achieved.

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Section: Discussionmentioning

confidence: 99%

Section: Study Interventionmentioning

confidence: 99%

Clarifying practical aspects of posterior tibial nerve stimulation for neurogenic overactive bladder: A scoping review

Terzoni,

Ferrara,

Di Schiena

et al. 2024

Int J of Uro Nursing

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“…TASCI is a nationwide, randomised, sham-controlled, double-blind clinical trial investigating the effects of TTNS in patients with acute SCI. 32 The intervention will take place during the inpatient rehabilitation stay in one of the four SCI centres in Switzerland (Basel: REHAB Basel, Nottwil: Swiss Paraplegic Center, Sion: Clinique romande de réadaptation, and Zürich: Balgrist University Hospital). Furthermore, TASCI is nested in the inception cohort of the prospective Swiss Spinal Cord Injury (SwiSCI) cohort study.…”

Section: Methods and Analysesmentioning

confidence: 99%

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

et al. 2020

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IntroductionNeurogenic 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 analysisTASCI 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 disseminationTASCI 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 numberNCT03965299.

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“…Employing cohort data for RCT planning provides advantages for trial design. As a case in point, we present results from the planning phase of TASCI (Transcutaneous tibial nerve stimulation in patients with Acute Spinal Cord Injury to prevent neurogenic detrusor overactivity: a nationwide randomized, sham-controlled, double-blind clinical trial) [ 13 , 14 ], which is nested in the Swiss Spinal Cord Injury Cohort Study (SwiSCI) [ 15 ]. TASCI aims to investigate the efficacy of transcutaneous tibial nerve stimulation (TTNS) in preventing the development of detrusor overactivity after spinal cord injury (SCI).…”

Section: Introductionmentioning

confidence: 99%

Optimizing clinical trial design using prospective cohort study data: a case study in neuro-urology

et al. 2020

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Study Design Simulations using data from a prospective cohort study. Objectives To illustrate how prospective cohort data can be employed in randomized controlled trial (RCT) planning to assess feasibility and operational challenges, using TASCI (Transcutaneous tibial nerve stimulation in patients with Acute Spinal Cord Injury to prevent neurogenic detrusor overactivity: a nationwide randomized, sham-controlled, double-blind clinical trial) as a case study. Setting Spinal cord injury rehabilitation centers in Switzerland. Methods TASCI is nested in the multicenter Swiss Spinal Cord Injury Cohort Study (SwiSCI), which prospectively includes patients with acute spinal cord injury. In simulations, data from 640 patients, collected by SwiSCI, were used to investigate different scenarios of patient eligibility and study consent, as well as the performance of the randomization list. Descriptive analysis was used to describe the population of interest and the simulation results; multivariable logistic regression analysis was performed to identify predictors of discharge within the TASCI intervention time period. Results The recruitment target of 114 patients is obtainable within the originally envisioned three-year time period under the most favorable recruitment scenario examined. The distribution of the primary prognostic factor produced imbalance in the randomization lists and informed further discussion of the cut-off values used in stratification. Influxes of patients resulted in overlapping intervention periods for multiple participants, which guided resource allocation. Early discharge was related to the primary prognostic factor and study center, but is only anticipated in about 8% of participants. Conclusions Prospective cohort data are a very valuable resource for planning RCTs.

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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

Cited by 6 publications

References 7 publications

Clarifying practical aspects of posterior tibial nerve stimulation for neurogenic overactive bladder: A scoping review

Clarifying practical aspects of posterior tibial nerve stimulation for neurogenic overactive bladder: A scoping review

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

Optimizing clinical trial design using prospective cohort study data: a case study in neuro-urology

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