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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02315560
Eligibility Criteria:
Inclusion Criteria:
1. Children ages 5 to 16 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history
2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
3. Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
4. Having been assessed for and treated if applicable for constipation
Exclusion Criteria:
1. Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
2. Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
3. Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
4. Children who are not adequately potty trained
5. Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
5\. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment
6\. Children with any implantable medical devices such as a pacemaker will be excluded from the study
Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT02315560
Study Brief:
Protocol Section:
NCT02315560