Expired Study
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Houston, Texas 77030


Purpose:

The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).


Study summary:

In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.


Criteria:

Inclusion Criteria: - Enrollment within 6 weeks of injury - Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord. - Location and transportation available for follow-up appointments Exclusion Criteria: - History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy - Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.) - History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.) - Pregnancy - History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.) - Morbid obesity - Ventilator dependent respiration - Significant autonomic dysreflexia during baseline urodynamic study.


NCT ID:

NCT02573402


Primary Contact:

Principal Investigator
Argyrios Stampas, MD
University of Texas at Houston Health Science Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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