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

The University of Texas System (UT)

Status: Completed

Conditions: Neurogenic Bladder; Spinal Cord Injury

Treatments: Device: Transcutaneous Tibial Nerve Stimulation; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02573402

HSC-MS-15-0806

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Transcutaneous Tibial Nerve Stimulation

Experimental group

Description:

Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.

Treatment:

Device: Transcutaneous Tibial Nerve Stimulation

Control

Sham Comparator group

Description:

Sham stimulation.

Treatment:

Device: Control