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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06169969
Eligibility Criteria:
IInclusion Criteria:
* Male Participants ages 20 to 35 years
* Participants will be a stable American Spinal Injury Association Impairment Scale (AISA) A/B.
* Motor incomplete spinal cord injury between spinal levels T6-T12.
* Participants present for more than 1 year.
* Each participant will require at least three prior urodynamic studies to confirm the diagnosis of neurogenic bladder with detrusor sphincter dyssynergia (DSD), which was diagnosed with urodynamic study.
Exclusion Criteria:
* Patients with a history of autonomic dysreflexia.
* Any patient who will be ventilator dependent, abusing drugs, have musculoskeletal dysfunction (i.e., unstable fractures).
* Any patient who will have cardiopulmonary diseases, active infections or ongoing depression requiring treatment, or have previous exposure to and use of spinal cord stimulation.
* Patients with a history of bladder Botox injection or bladder/sphincter surgeries.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT06169969
Study Brief:
Protocol Section:
NCT06169969