Using nerve stimulation to improve bladder function in acute spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of transcutaneous tibial nerve stimulation (TTNS) on patients with acute spinal cord injury (SCI) to prevent neurogenic lower urinary tract dysfunction (NLUTD). It is a nationwide, randomized, sham-controlled, double-blind multicentre trial conducted across various SCI centers in Switzerland. Participants will be randomly assigned to receive either active TTNS or sham stimulation for 30 minutes daily, five times a week, over a period of 6-9 weeks. The primary outcome is the success of the intervention in improving bladder function and preventing complications associated with NLUTD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>18 years
* Patients with acute SCI (traumatic SCI and sudden onset (\<7 days) non-traumatic SCI) within 40 days after injury
* Patients with acute SCI at cervical or thoracic level
* Willing to take part and follow the requirements of the TASCI protocol (up to one year after SCI)

  * no percutaneous tibial nerve stimulation (PTNS)
  * no functional electrical stimulation (FES), apart from upper limb FES
  * no electrical muscle stimulation (EMS)
* Informed Consent

Exclusion Criteria:

* Contraindications to the investigational product
* DO with contractions greater than 40 cmH2O at a bladder filling volume of less than 500mL at baseline visit
* Treatment with antimuscarinics or with mirabegron
* Known or suspected non-adherence, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug or product within the 30 days preceding and during the present study
* Neuromodulation treatment for urological or bowel indication in the last six months or ongoing
* Botulinum toxin injections in the detrusor and/or urethral sphincter in the last six months
* Bilaterally absent tibial nerve compound muscle action potential (cMAP, amplitude \< 1mV)
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences \[www.samw.ch/en/News/News.html\])
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Pre-existing or concomitant medical condition apart from SCI that might pose a safety issue or would interfere with interpretation of study results or study conduct (e.g. Parkinson's disease, neurodegenerative disorders including multiple sclerosis and amyotrophic lateral sclerosis, urological malignancies)

Where it's running

• Department of Neuro-Urology, Spinal Cord Injury Centre & Research, Balgrist University Hospital
  Zurich, Canton of Zurich, Switzerland Recruiting
• REHAB Basel
  Basel, Switzerland Recruiting
• Swiss Paraplegic Centre
  Nottwil, Switzerland Recruiting
• Spinal Cord Injury Department, Clinique romande de réadaption
  Sion, Switzerland Recruiting

Study contacts

• Principal investigator: Thomas M. Kessler, Prof. Dr. med. — Balgrist University Hospital
• Study coordinator: Thomas M. Kessler, Prof. Dr. med.
• Email: thomas.kessler@balgrist.ch
• Phone: +41 44 386 39 07

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.