Foot Neuromodulation for Overactive Bladder in Children

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

Study Overview

• Status: Withdrawn
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulator (TENS)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh og UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Electrical stimulation; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajeev Chaudhry
• Investigators: Principal Investigator: Rajeev Chaudhry, MD, University of Pittsburgh

Publications and helpful links

General Publications

• stimulation in cats. J Urol 2011;186(1):326-30. 2. Chen M, Chermansky C, et al. Electrical stimulation of somatic afferent nerves in the foot increase bladder capacity in healthy human subjects. J Urol. April 2014, 191:1009-1013. 3. Gaziev G, Topazio L, et al. Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urology. 2013, 13:61-72. 4. Sillen U, Arwidsson C, et al. Effects of transcutaneous neuromodulation (TENS) on overactive bladder symptoms in children: A randomized clinical trial. J Pediatr Urol. 2014, in press - accepted 30 March 2014 5. Barroso U, Viterbo W, et al. Posterior tibial nerve stimulation vs parasacral transcutaneous neuromodulation for overactive bladder in children. J Urol. Aug 2013, 190(2):673-677 6. DeGannaro M, Capitanucci ML, et al. Current state of stimulation technique for lower urinary tract dysfunction in children. J Urol. May 2011; 185(5):1571-7. 7. Lordelo P, Teles A, et al. Transcutaneous electrical stimulation in children with overactive bladder: a randomized clinical trial. J Urol. Aug 2010;184(2):683-9. 8. Malm-Buatsi E, NeppleKG, et al. Efficacy of transcutaneous electrical nerve stimulation in children with overactive bladder refractory to pharmacotherapy. Urology 2007. Nov; 70(5):980-3.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: PRO14080117