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Purpose

The purpose of this study is to determine the safety, feasibility, and compliance of a daily home transcutaneous tibial nerve stimulation (tTNS) protocol in children with chronic neurogenic bladder (NB) provided by self or caregiver for 4 weeks and to estimate the efficacy of tTNS

Condition

Eligibility

Eligible Ages
Between 4 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • chronic neurogenic bladder - Spina Bifida diagnosis - Use of overactive bladder medication(s) - Stable bladder medications for ≥ 3 months

Exclusion Criteria

  • Progressive SCI (ex: transverse myelitis, polio, etc.) - Other lower urinary tract pathology or surgery - 2+ pitting edema in the legs that does not resolve - Known peripheral neuropathy or injury to the path of the tibial nerve - Cancer in the tibial nerve pathway and/or lower urinary tract - Inability to elicit the motor response with electric stimulation - Inability to complete the tTNS proficiency checklist (guardians) - Non-English speaking (guardians)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Stamobil electric stimulator
  • Device: Stamobil electric stimulator
    The electric stimulation protocol will use stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode for 30 minutes daily. The goal is daily use of tTNS for 4 weeks , 5 days per week.
Sham Comparator
sham tTNS device
  • Device: sham tTNS device
    The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week

Recruiting Locations

The University of Texas Health Science Center and Houston
Houston, Texas 77030
Contact:
Argyrios Stampas, MD,MS
713-797-5007
Argyrios.Stampas@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Argyrios Stampas, MD, MS
(713) 797-5007
Argyrios.Stampas@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.