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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02816151
Eligibility Criteria:
inclusion criteria
* Old ≥3 years and ≤15 years
* Syndrome of vesical hyperactivity associated with a manometric detrusor hyperactivity
* Neurogenic vesico-sphincter disorders
* Anticholinergic treatment total/partial Failure/ intolerance
* Native Bladder and TB virgin
* Bladder patient or ready to be it, or possibly straight bladder
* 3 months delay if TB injection in another site
* Agreement to stop anticholinergic treatment 1 month before and throughout all protocol
non- inclusion criteria
* Toxin Botulinic use counter-indication (myasthenia, infantil spinal amyotrophy)
* General anaesthesia counter-indication
* Haemostasis disorders
* Children less than 3 years and more than 16 years
* non-neurogenic vesical hyperactivity
* Good tolerance and effectiveness of the anticholinergic treatment
* Bladder increased or already treated by one or more Toxin injections
* Having toxin injection in another site since less than 3 months
* Child wouldn't sondered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
15 Years
Study:
NCT02816151
Study Brief:
Protocol Section:
NCT02816151