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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT04935918
Eligibility Criteria:
Inclusion Criteria:
* Boys and girls \> 5 years with bladder exstrophy or isolated epispadias;
* sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, stress urinary incontinence);
* normal renal function (eGFR \> 90ml/min);
* no (or stable) upper urinary tract dilatation in ultrasound.
Exclusion Criteria:
* under 5 years or more than 18 years old;
* renal insufficiency (acute or chronic);
* evolutive deterioration of the upper urinary tract (hydronephrosis);
* unmanageable detrusor instability;
* residual volume greater than 100 ml after voiding;
* bleeding disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT04935918
Study Brief:
Protocol Section:
NCT04935918