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Foot Neuromodulation for Overactive Bladder in Children

Primary Purpose

Overactive Bladder

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous Electrical Nerve Stimulator (TENS)

About this trial

This is an interventional other trial for Overactive Bladder

Eligibility Criteria

5 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Children's Hospital of Pittsburgh og UPMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical stimulation

Arm 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.

Outcomes

Primary Outcome Measures

Number of participants with decreased urinary frequency

Foot stimulation decreases urinary frequency measured by a daily voiding diary.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02320201

First Posted

December 3, 2014

Last Updated

December 22, 2022

Sponsor

Rajeev Chaudhry

1. Study Identification

Unique Protocol Identification Number

NCT02320201

Brief Title

Foot Neuromodulation for Overactive Bladder in Children

Official Title

Foot Neuromodulation for Overactive Bladder in Children

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Not enough patients enrolled for analysis.

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rajeev Chaudhry

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electrical stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcutaneous Electrical Nerve Stimulator (TENS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants with decreased urinary frequency

Description

Foot stimulation decreases urinary frequency measured by a daily voiding diary.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Number of participants with improved over active bladder symptoms

Description

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

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rajeev Chaudhry, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Pittsburgh og UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

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Foot Neuromodulation for Overactive Bladder in Children

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