Shocking bladder trouble away: nerve zap trial for spinal injury patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)