Expired Study
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Pittsburgh, Pennsylvania 15224


Purpose:

To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children


Study summary:

Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting their use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.


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.


NCT ID:

NCT02315560


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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