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TTNS-RCT: Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT04074616
Collaborator
National Center for Advancing Translational Science (NCATS) (NIH)
60
Enrollment
1
Location
2
Arms
33.5
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home

Condition or Disease Intervention/Treatment Phase
  • Device: High Dose
  • Device: Low dose
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized sham-control trialrandomized sham-control trial
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The Study is designed to look at the difference in "high dose" group, which will be submotor amperage, compared to "low dose" which will be set to 1 mA. Both groups will need to stimulate the tibial nerve and visualize toe movement, and then decrease to the amperage of either "high dose" or "low dose." Both groups will use the device for 30 minutes, 5 days per week. A urodynamic study will be performed to measure bladder capacity, sensations while filling, and detrusor pressures before starting using the device and one last time at the end of the study. We are also conducting surveys to describe differences in preferences with using bladder medications versus devices.
Primary Purpose:
Treatment
Official Title:
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Actual Study Start Date :
Nov 19, 2019
Anticipated Primary Completion Date :
Sep 5, 2022
Anticipated Study Completion Date :
Sep 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Dose

Device: High Dose
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks,with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.
Other Names:
  • TTNS stimulation

    		•
    Other: Control

    Low dose TTNS

    Device: Low dose
    Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
    Other Names:
  • TTNS stimulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with reduction in bladder medication [3 months after subject enrollment]

    2. Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the neurogenic bladder symptom score (NBSS)scale. [3 months after subject enrollment]

      The NBSS scale consists of 24 questions each with a score ranging form 0-4.Higher the score indicates a worse outcome.

    3. Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the voiding dairy [3 months after subject enrollment]

    Secondary Outcome Measures

    1. Number of participants with improved quality of life as assessed by the I-QOL questionnaire [3 months after subject enrollment]

    2. Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey [3 months after subject enrollment]

    3. Number of participants with stable or improved bladder capacity as assessed by the urodynamic study [At baseline and 3 month after subject enrollment]

      urodynamic study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Traumatic and non-traumatic SCI performing IC

    • Up to 2 anticholinergic overactive bladder (OAB) medications

    • No changes in OAB medications

    • Neurologic level of injury above T10

    • English and Spanish speaking

    Exclusion Criteria:

    • Past history of genitourinary diagnoses or surgeries

    • History of central nervous system (CNS) disorders and/or peripheral neuropathy

    • Pregnancy

    • Lower motor neuron bladder

    • Concern for tibial nerve pathway injury

    • Absence of toe flexion or AD with electric stimulation

    • Bladder chemodenervation in past 6 months

    • Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston
    • National Center for Advancing Translational Science (NCATS)

    Investigators

    • Principal Investigator: Argyos Stampas, MD, UTHealth

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Argyrios Stampas, MD, Associate Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT04074616
    Other Study ID Numbers:
    • HSC-MS-19-0518
    • KL2TR003168
    First Posted:
    Aug 30, 2019
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Argyrios Stampas, MD, Associate Professor, The University of Texas Health Science Center, Houston
    electric stimulation
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Urinary Bladder, Neurogenic
    Wounds and Injuries

    Study Results

    No Results Posted as of May 27, 2022