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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT04313192
Eligibility Criteria:
Inclusion Criteria:
1. Presenting with nocturnal enuresis (more than 1x a week)
2. Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors)
3. Ability to provide informed consent and assent and complete study requirements
Exclusion Criteria:
1. Patients who have previously tried pharmacologic treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic disorders within the past 30 days
2. Daytime incontinence symptoms
3. Known "high volume" voiders (determined from history)
4. Bedwetting episodes on the average of less than two times per week,
5. Medications predisposing to incontinence (eg, Lithium for bipolar disorder)
6. Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc)
7. Secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae, heart disease)
8. Any contraindications to usage of a TENS unit (pacemaker or other implantable device, lymphedema, pregnancy, malignancy,bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition)
9. Any history of heart disease or complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT04313192
Study Brief:
Protocol Section:
NCT04313192