Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder (TTNS1yr)

June 21, 2023 updated by: Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly.

Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose."

TTNS will be used 5 days weekly, per our pilot trial. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. All subjects will continue for 1-year post-SCI.

Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar National Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Suzzane Groah, MD., MSPH
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • TIRR Memorial Hermann Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Argyrios Stampas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-75 years old
  • Traumatic or non-traumatic SCI
  • Admitted to inpatient rehabilitation within 6 weeks
  • T9 level of injury and above who are at greatest risk of morbid NGB
  • Regionally located to allow follow-up
  • English or Spanish speaking

Exclusion Criteria:

  • History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
  • History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
  • History of peripheral neuropathy
  • pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
  • Pregnancy
  • Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy
  • concern for tibial nerve pathway injury
  • absence of toe flexion or autonomic dysreflexia during electric stimulation test
  • Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Variable-dose TTNS Protocol 5 x week

TTNS protocol: 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 there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.

All participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci.
Device: Variable-dose TTNS Protocol 5 x week
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 there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Active Comparator: Fixed-dose TTNS protocol

Fixed-dose protocol: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes.

Both variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per week.
Device: Fixed-dose TTNS Protocol
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
Active Comparator: Variable-dose TTNS Protocol 2 x week
At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
Device: Variable-dose TTNS Protocol 2 x week
At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time Frame: Baseline
we expect bladder capacity to be maintained in those with effective TTNS
Baseline
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time Frame: 4 months post SCI
we expect bladder capacity to be maintained in those with effective TTNS
4 months post SCI
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time Frame: Baseline
Evidence of TTNS mechanism expected in those with effective TTNS
Baseline
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time Frame: 4 months post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
4 months post SCI
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time Frame: 1 year post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
1 year post SCI
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
Time Frame: Baseline, 4 months
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Baseline, 4 months
Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.
Time Frame: 4 months and 1 year post SCI
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on the change in urodynamic studies at 4 months and 1-year
4 months and 1 year post SCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey
Time Frame: At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.
Comparing I-QOL upon discharge from rehabilitation, 4-months post-injury and 1-year post-injury using incontinence QOL (I-QOL) survey, between and within both arms of the study
At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.
Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)
Time Frame: Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.
Changes in Neurogenic Bladder Symptom Scores. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms) where a lower score indicates a better outcome.
Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.
Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes
Time Frame: 2 days at the end of each month for 1 year.
Maintaining frequency of catheterization (count per day) and volumes per void (ml per collection)
2 days at the end of each month for 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

The Methodist Hospital Research Institute
MedStar National Rehabilitation Network

Investigators

  • Principal Investigator: Argyrios Stampas, MD, UTHealth and TIRR Mermorial Hermann
  • Principal Investigator: Suzanne Groah, MD, MedStar National Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-19-0756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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