Foot Neuromodulation for Overactive Bladder in Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Rajeev Chaudhry
- Locations
- 1
- Primary Endpoint
- Number of participants with decreased urinary frequency
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Rajeev Chaudhry
Assistant Professor
University of Pittsburgh
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of participants with decreased urinary frequency
Time Frame: 3 weeks
Foot stimulation decreases urinary frequency measured by a daily voiding diary.
Secondary Outcomes
- Number of participants with improved over active bladder symptoms(3 weeks)