Foot Neuromodulation for Overactive Bladder in Children

Rajeev Chaudhry

Status: Withdrawn

Conditions: Overactive Bladder

Treatments: Device: Transcutaneous Electrical Nerve Stimulator (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02320201

PRO14080117

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Electrical stimulation

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulator (TENS)