Overactive Bladder
Conditions
Brief summary
To determine the effects of electrical stimulation of the nerves in the foot on overactive bladder conditions in children.
Detailed description
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.
Interventions
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.
Sponsors
Rajeev Chaudhry
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with decreased urinary frequency | 3 weeks | Foot stimulation decreases urinary frequency measured by a daily voiding diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with improved over active bladder symptoms | 3 weeks | 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 |
Countries
United States
Outcome results
None listed