Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT05504200
Eligibility Criteria:
Inclusion Criteria:
* Supra-sacral spinal cord injury over 6 months ago
* Previous urodynamics and management by the Neuro-urology Consultants
* Proven NDO from latest urodynamics
Exclusion Criteria:
* Participants under 16 years of age
* Non-stable SCI or metastatic cord disease
* Intra-detrusor botulinum toxin injections in previous 6 months
* Bladder infection on day of investigation
* Pregnant or trying for a baby (females)
* Cardiac pacemaker, bladder stimulator or baclofen pump in situ
* Metal work at thoraco-lumbar level of stimulation
* Poorly controlled Autonomic Dysreflexia
* Currently involved in a clinical trial
* Previous surgical intervention on bladder/sphincters
* Active sepsis
* Poorly controlled epilepsy. Acceptable where epilepsy is controlled by drugs or there have been no fits experienced for a reasonable period
* Patients with a cancerous tumour in the area of the electrical stimulation
* Patients without the capacity to consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05504200
Study Brief:
Protocol Section:
NCT05504200