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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT02900495
Eligibility Criteria:
Inclusion Criteria:
* primary nocturnal enuresis
* wet nights occur more than once per week on average
* Failed Behavioral therapy treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors)
* ability to provide informed consent and complete study requirements
Exclusion Criteria:
* the use of medications for nocturnal enuresis (DDAVP, imipramine, anticholinergics) less than 30 days from time of appointment
* daytime incontinence
* Known "high volume" voiders
* medications predisposing to incontinence (eg, Lithium for bipolar disorder)
* other known voiding or neurologic disorders (eg, overactive bladder, spina bifida, interstitial cystitis)
* secondary etiologies for nocturnal enuresis (cystitis, obstructive sleep apnea, urinary fistula)
* any contraindication to TENS unit usage (pacemaker or other implantable devices, lymphedema, pregnancy, malignancy)
* Any history of heart disease or complications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT02900495
Study Brief:
Protocol Section:
NCT02900495