Using nerve stimulation to improve bladder function in acute spinal cord injury
Transcutaneous Tibial Nerve Stimulation in Patients With Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity: A Nationwide Randomised, Sham-controlled, Double-blind Clinical Trial
NA · University of Zurich · NCT03965299
This study is testing whether a nerve stimulation treatment can help people with recent spinal cord injuries improve their bladder function and avoid related problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich (other) |
| Locations | 4 sites (Zurich, Canton of Zurich and 3 other locations) |
| Trial ID | NCT03965299 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with acute spinal cord injury occurring within the last 40 days.
Not a fit: Patients with severe bladder dysfunction or those currently undergoing other specific bladder treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve bladder function and quality of life for patients with acute spinal cord injury.
How similar studies have performed: Previous studies have shown promise in using neuromodulation techniques for bladder dysfunction, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zurich, Canton of Zurich and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injury, Acute, randomized, sham-controlled, double-blind trial, transcutaneous tibial nerve stimulation, spinal cord injury, neurogenic detrusor overactivity, neuromodulation, electrical stimulation, paraplegia