Foot Neuromodulation for Overactive Bladder in Children

Not Applicable

Withdrawn

• Conditions: Overactive Bladder
• Interventions: Device: Transcutaneous Electrical Nerve Stimulator (TENS)

• Registration Number: NCT02320201
• Lead Sponsor: Rajeev Chaudhry

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrical stimulation	Transcutaneous Electrical Nerve Stimulator (TENS)	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with decreased urinary frequency	3 weeks	Foot stimulation decreases urinary frequency measured by a daily voiding diary.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh og UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States