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:
2025-12-24 @ 11:54 AM
Ignite Modification Date:
2025-12-24 @ 11:54 AM
NCT ID:
NCT05380661
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18-70 years of age
* Any chronic traumatic SCI with either motor sensory complete injury (AIS A/B, N=10) or motor sensory incomplete injury (AIS B/D, N=10).
* At least 1 year post injury, and at least 6 months from any spinal surgery
* Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage
* Must provide informed consent and be able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator)
* Willing and able to comply with clinic visit and study-related procedures
Exclusion Criteria:
* Signs or known current urinary tract infection, or other inflammatory conditions of bladder/urethra
* Currently taking beta blockers or other medications that may affect heart rate
* History of ureteral injury
* History of any urinary diversion procedures, including but not limited to bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy
* For women of childbearing potential, currently pregnant
* A member of the investigational team or his/her immediate family Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05380661
Study Brief:
Protocol Section:
NCT05380661