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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02573402
Eligibility Criteria:
Inclusion Criteria:
* Enrollment within 6 weeks of injury
* Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord.
* Location and transportation available for follow-up appointments
Exclusion Criteria:
* History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy
* Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.)
* History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
* Pregnancy
* History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
* Morbid obesity
* Ventilator dependent respiration
* Significant autonomic dysreflexia during baseline urodynamic study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02573402
Study Brief:
Protocol Section:
NCT02573402