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Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

NCT04350359

CompletedNA

Sponsor: The University of Texas Health Science Center, Houston

Conditions: Spinal Cord Injuries

Interventions: Variable-dose TTNS Protocol 5 x week, Fixed-dose TTNS Protocol, Variable-dose TTNS Protocol 2 x week

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (2)
  • Washington D.C., District of Columbia, United States
  • Houston, Texas, United States