Foot Neuromodulation for Overactive Bladder in Children

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

Detailed Description
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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.

Official Title
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Foot Neuromodulation for Overactive Bladder in Children

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Transcutaneous Electrical Nerve Stimulator (TENS)


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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical stimulation<br>Transcutaneous Electrical Nerve Stimulator (TENS) will be applied to the foot via skin surface electrodes for a minimum of 2 hours per day for 1 week to 20 subjects. Subjects will be required to keep a daily voiding diary for one week before treatment to establish a control, during the treatment week and for one week after treatment. Subjects will also be asked to complete a validated questionnaire prior to treatment, during treatment week and one week after treatment. The primary outcomes of this study are improvement in objective measures of frequency as indicated by voiding diary and subjective symptom improvement based on questionnaire comparison. | Device: Transcutaneous Electrical Nerve Stimulator (TENS)<br>* Electrical stimulation will be applied to the foot via skin surface electrodes for a minimum of 2 hours per day for 1 week to 20 subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with decreased urinary frequency | Foot stimulation decreases urinary frequency measured by a daily voiding diary. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with improved over active bladder symptoms | Foot stimulation improves OAB symptoms over the course of 3-week period, with foot stimulation applied during the second week measured by a validated symptom survey | 3 weeks |