Expired Study
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Pittsburgh, Pennsylvania 15224


Purpose:

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


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

PRO14080117


NCT ID:

NCT02320201


Secondary ID:


Study Acronym:


Brief Title:

Foot Neuromodulation for Overactive Bladder in Children


Official Title:

Foot Neuromodulation for Overactive Bladder in Children


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

5 Years


Maximum Age:

16 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Rajeev Chaudhry, MD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:September 2014
Completion Date:December 2020
Completion Type:Anticipated
Primary Completion Date:September 2020
Primary Completion Type:Anticipated
Verification Date:October 2019
Last Changed Date:October 1, 2019
First Received Date:December 3, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of participants with decreased urinary frequency
Time Frame:3 weeks
Safety Issues:False
Description:Foot stimulation decreases urinary frequency measured by a daily voiding diary.
Outcome Type:Secondary Outcome
Measure:Number of participants with improved over active bladder symptoms
Time Frame:3 weeks
Safety Issues:False
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

Study Interventions

Intervention Type:Device
Name:Transcutaneous Electrical Nerve Stimulator (TENS)
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.
Arm Name:Electrical stimulation

Study Arms

Study Arm Type:Experimental
Arm Name:Electrical stimulation
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 th

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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