The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury



Status:Completed
Conditions:Other Indications, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 65
Updated:9/12/2018
Start Date:July 12, 2016
End Date:October 27, 2017

Use our guide to learn which trials are right for you!

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).

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.

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.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials