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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.
10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Participants With Infection
All infections were urinary tract infections (UTIs).
Time frame: about 4 weeks
Number of Participants With Skin Irritation
Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.
Time frame: about 4 weeks
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
Time frame: about 4 weeks
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)
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.
Time frame: baseline, about 30 minutes
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Time frame: baseline
Maximum Detrusor Pressure as Evaluated by Urodynamic Study
Time frame: 2 weeks
Maximum Bladder Capacity as Evaluated by Urodynamic Study
Time frame: baseline
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Maximum Bladder Capacity as Evaluated by Urodynamic Study
Time frame: 2 weeks