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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT01565694
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of NDO, confirmed by urodynamics
* Practicing clean intermittent catheterization (CIC)
* Currently on treatment with an antimuscarinic drug
Exclusion Criteria:
* Known genitourinary condition (other than NDO) that may cause incontinence
* Bladder augmentation surgery
* Current Faecal impaction
* Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
* Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
* Reflux grade 3 or 4
* Current urinary tract infection (UTI)
* Subject has severe renal impairment (glomerular filtration rate \< 30 ml/min)
* Subject has severe hepatic impairment (Child-Pugh score \> 9).
* Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT01565694
Study Brief:
Protocol Section:
NCT01565694