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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT02336906
Eligibility Criteria:
Inclusion Criteria:
1. Aged 5-17 years at time of signing of informed consent.
2. Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of \>11 on the Vancouver Questionnaire .
3. Do not meet Rome III criteria for functional constipation.
Exclusion Criteria:
1. Inability to provide signed informed consent.
2. Inability to comply with the study protocol.
3. Neurogenic bladder
4. Attention Deficit Disorder (ADD or ADHD) on medical treatment.
5. Known significant sacral, perineal, or other congenital or surgical defect.
6. Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
7. Patient taking medicinal drugs which can cause urinary incontinence or constipation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT02336906
Study Brief:
Protocol Section:
NCT02336906