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

Not Applicable

Completed

Interventions: Device: Transcutaneous Tibial Nerve Stimulation
Device: Control

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Transcutaneous Tibial Nerve Stimulation	Transcutaneous Tibial Nerve Stimulation	Transcutaneous Tibial Nerve Stimulation (TTNS) applied to subjects for 2-week protocol.
Control	Control	Sham stimulation.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital	about 4 weeks
Number of Participants With Skin Irritation	about 4 weeks	Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.
Number of Participants With Infection	about 4 weeks	All infections were urinary tract infections (UTIs).
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)	baseline, about 30 minutes	Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's "mean change in pain score": \[Average of the post-stimulation measurements for all 10 time points\] minus \[Average of baseline measurements for all 10 time points time point\] = \[mean change in pain score\]. The value reported is the mean of all participants' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain.