Foot Neuromodulation for Overactive Bladder in Children

NCT02320201 | Withdrawn

• 1 other identifier: PRO14080117
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Number of participants with decreased urinary frequency

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

  3 weeks

Secondary Outcomes (1)

• Number of participants with improved over active bladder symptoms

  3 weeks

Study Arms (1)

Electrical stimulation

EXPERIMENTAL

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)

Interventions

Transcutaneous Electrical Nerve Stimulator (TENS) DEVICE

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.

Electrical stimulation

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajeev Chaudhry: lead

Study Sites (1)

Children's Hospital of Pittsburgh og UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajeev Chaudhry, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 19, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

US (1)