Expired Study
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Pittsburgh, Pennsylvania 15224


Purpose:

To determine the effects of electrical stimulation of the nerves in the foot on overactive bladder conditions in children.


Study summary:

Bladder overactivity in the pediatric population presents a more challenging clinical situation than in adults after failure of medical therapy, as other treatments with proven efficacy such as botulinum injections and interstim sacral nerve stimulators are too invasive for the routine use in children. A non-invasive, effective way to improve overactive bladder in this population would have a great impact on a child's quality of life.


Criteria:

Inclusion Criteria: 1. Children ages 5 to 16 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as idiopathic over active bladder (OAB) 2. Currently having OAB symptoms, i.e. urinary frequency, urgency, or incontinence 3. Having been assessed for and treated if applicable for behavioral etiologies of OAB - holding urine too long, consuming excess caffeine or other bladder irritants. 4. Having been assessed for and treated if applicable for constipation Exclusion Criteria: 1. Patients with known neurological disorders which may be contributing to OAB symptoms 2. Patients found through history to have significant behavioral causes of OAB including consumption of known bladder irritants and dysfunctional voiding. 3. Patients with chronic constipation who are non-compliant with previous pharmacologic efforts to treat. 4. Patients who are not adequately potty trained 5. Patients 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:

NCT02320201


Primary Contact:

Principal Investigator
Rajeev Chaudhry, MD
Children's Hospital of Pittsburgh of UPMC


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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