Foot Neuromodulation for Overactive Bladder in Children



Status:Enrolling by invitation
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:5 - 16
Updated:10/13/2018
Start Date:September 2014
End Date:December 2019

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

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.

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.
We found this trial at
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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