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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT04620356
Eligibility Criteria:
Inclusion Criteria:
* Patient aged between 4-8 years at the time of enrollment
* Have a clinical diagnosis of monosymptomatic primary NE
* Have been dry in the day for \>/= 6 months prior to enrollment
* Have on average no more than 1 dry night per month during the past 6 months at enrollment
* Have an informed consent signed by the their parent(s)/carer(s)
Exclusion Criteria:
* Children in foster/court care
* Have implemented any previous intervention to address NE (use of prescribed alarm schedule, desmopressin, imipramine, anticholinergics) or withdrawal of pants/nappies for \> 7 days in the previous 6 months
* Have secondary NE
* Have wetting in the day
* Have faecal soiling
* Have known urinary tract disease
* Have diabetes
* Receive any regular intake of medication
* Have a known developmental/neurological disorder
* Have links to Kimberly-Clark of any kind (including family relations employed by Kimberly-Clark, holding stocks or share in Kimberly-Clark)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT04620356
Study Brief:
Protocol Section:
NCT04620356