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Completed

NCT Number: NCT04350359

Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar National Rehabilitation Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Variable-dose TTNS Protocol 5 x week

Device

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.

Fixed-dose TTNS Protocol

Device

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.

Variable-dose TTNS Protocol 2 x week

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • MedStar National Rehabilitation Network
  • The Methodist Hospital Research Institute

Registry information

Acronym: TTNS1yr

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2020
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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