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

BMJ Open, 2020 · DOI: 10.1136/bmjopen-2020-039164 · Published: June 9, 2020

Simple Explanation

This paper outlines a clinical trial protocol investigating transcutaneous tibial nerve stimulation (TTNS) for preventing neurogenic detrusor overactivity (NDO) in acute spinal cord injury (SCI) patients. The study, named TASCI, aims to evaluate TTNS efficacy in preventing NDO, understand the mechanisms of TTNS, and observe NLUTD development post-SCI. It is a nationwide, randomised, sham-controlled, double-blind clinical trial conducted across four Swiss SCI centers.

Study Duration

12 months follow-up

Participants

114 patients with acute SCI

Evidence Level

Level 1: Randomized, sham-controlled, double-blind clinical trial

Key Findings

1
The primary outcome is the occurrence of NDO jeopardising the upper urinary tract at 1 year after SCI, assessed by urodynamic investigation.
2
Secondary outcomes assess bladder and bowel function, sexual function, neurological structure, functional independence, quality of life, and changes in biomarkers.
3
The study also evaluates the safety of TTNS as a tertiary outcome.

Research Summary

The TASCI trial is designed to evaluate the efficacy of TTNS in preventing NDO in patients with acute SCI. The study is a nationwide, randomized, sham-controlled, double-blind clinical trial conducted at all four SCI centers in Switzerland. The longitudinal design includes baseline assessments and follow-up assessments occurring 3, 6, and 12 months after SCI.

Practical Implications

Clinical Practice

The study results could revolutionize clinical practice by shifting the approach to NLUTD management from treating manifested problems to preventing the disorder itself.

Economic Impact

An effective preventative measure could eliminate lifelong issues associated with SCI, lowering barriers to work force participation and improving QoL, at the same time reducing lifetime healthcare costs.

Further Research

The study will provide conceptual insight regarding the mechanism of neuromodulation, and the developmental course of NLUTD following SCI.

Study Limitations

1
The intervention start at 29–40 days after SCI may modestly reduce the potential for neuroplasticity.
2
The study relies on participant adherence to the intervention protocol.
3
Temporary interruptions to recruitment due to the COVID-19 pandemic are a possibility.

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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

Simple Explanation

Key Findings

Research Summary

Practical Implications

Clinical Practice

Economic Impact

Further Research

Study Limitations

Your Feedback

Was this summary helpful?

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

Simple Explanation

Key Findings

Research Summary

Practical Implications

Clinical Practice

Economic Impact

Further Research

Study Limitations

Your Feedback

Was this summary helpful?

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

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