Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074616
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Argyrios Stampas, MD, The University of Texas Health Science Center, Houston

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
Chronic Spinal Cord Injury Neurogenic Bladder Device: High Dose Device: Low dose Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized 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 : November 19, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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 Name: TTNS stimulation

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 Name: TTNS stimulation




Primary Outcome Measures :
  1. Number of participants with reduction in bladder medication [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 3 months after subject enrollment ]

Secondary Outcome Measures :
  1. Number of participants with improved quality of life as assessed by the I-QOL questionnaire [ Time Frame: 3 months after subject enrollment ]
  2. Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey [ Time Frame: 3 months after subject enrollment ]
  3. Number of participants with stable or improved bladder capacity as assessed by the urodynamic study [ Time Frame: At baseline and 3 month after subject enrollment ]
    urodynamic study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074616


Contacts
Layout table for location contacts
Contact: Argyrios Stampas, MD 713-797-5938 argyrios.stampas@uth.tmc.edu
Contact: Vanessa Bernal, BS 713-797-7636 vanessa.bernal@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Stampas Argyrios, MD    713-797-5938    argyrios.stampas@uth.tmc.edu   
Contact: Vanessa Bernal    7137977636 ext l    vanessa.bernal@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Argyos Stampas, MD UTHealth
Publications:

Layout table for additonal information
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
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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, The University of Texas Health Science Center, Houston:
electric stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms