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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT01682603
Eligibility Criteria:
Inclusion Criteria:
* Adults with age of 19 years old or above
* Patients with chronic suprasacral cord SCI will be enrolled.
* Patients will be proven having NDO by videourodynamic study during the screening period.
* They also receive 99mTc-DTPA renal scanning for GFR at baseline.
* Patients with NDO induced urinary incontinence who have adequate hand function or have a care-giver available for CIC, and the baseline total GFR of less than 80 mL/min are main inclusion criteria
Exclusion Criteria:
* Patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency
* Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT01682603
Study Brief:
Protocol Section:
NCT01682603