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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT01852058
Eligibility Criteria:
Inclusion Criteria:
* Successfully completed participation in Study 191622-120
* Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
* Regularly using clean intermittent catheterization to empty the bladder
Exclusion Criteria:
* Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Current or planned use of a baclofen pump
* Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
* Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
* Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype for any other condition since entering study 191622-120
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT01852058
Study Brief:
Protocol Section:
NCT01852058