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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03351634
Eligibility Criteria:
Inclusion Criteria:
* Boys and girls \> 5 years with spinal dysraphism (occult or open)
* Neurogenic sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, urinary incontinence)
* Normal renal function (eGFR \> 90ml/min)
* No (or stable) upper urinary tract dilatation in ultrasound
* In case no compliante bladder ( bladder capacity \< 50% for the age) a concomitant injection of botox endoscopically will be performed
Exclusion Criteria:
* under 5 years with an acquired neurogenic bladder
* renal insufficiency (acute or chronic)
* evolutive deterioration of the upper urinary tract (hydronephrosis)
* active systemic or urinary tract infections
* unmanageable detrusor instability
* reduced bladder compliance
* residual volume greater than 100 ml after voiding
* bleeding disorders
* urethral stenosis
* who refused CIC
* patent sacral bedsore
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT03351634
Study Brief:
Protocol Section:
NCT03351634