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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT01263392
Eligibility Criteria:
Inclusion Criteria:
* Healthy Child with spina bifida who requires clean intermittent catheterization (CIC) for ongoing bladder management.
* Child either self catheterizes or receives catheterization by a consistent person.
* Child/parent/caregiver able to read and understand English in order to consent to participation in the study and to respond to verbal questions about the experience and satisfaction with the catheter.
Exclusion Criteria:
* Urethral deformities (i.e. stricture, false passage)
* Antibiotic prophylaxis
* Allergy to PVC product
* Diabetes Mellitus
* Unwilling to reuse catheters
* History of bladder pathology (ie. tumours, calculus)
* Surgical history of augmentation (cystoplasty, continent diversion)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Years
Study:
NCT01263392
Study Brief:
Protocol Section:
NCT01263392