The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly. Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose." TTNS will be used 5 days weekly, per our pilot trial. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. All subjects will continue for 1-year post-SCI. Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Electrodes 2 inch by 2 inch will be placed 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. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
RECRUITINGTIRR Memorial Hermann Research Center
Houston, Texas, United States
RECRUITINGMaintained bladder capacity as assessed by the Urodynamics study measured in ml
we expect bladder capacity to be maintained in those with effective TTNS
Time frame: Baseline
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
we expect bladder capacity to be maintained in those with effective TTNS
Time frame: 4 months post SCI
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Evidence of TTNS mechanism expected in those with effective TTNS
Time frame: Baseline
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Evidence of TTNS mechanism expected in those with effective TTNS
Time frame: 4 months post SCI
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Evidence of TTNS mechanism expected in those with effective TTNS
Time frame: 1 year post SCI
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Time frame: Baseline, 4 months
Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on the change in urodynamic studies at 4 months and 1-year
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At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
Time frame: 4 months and 1 year post SCI
Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey
Comparing I-QOL upon discharge from rehabilitation, 4-months post-injury and 1-year post-injury using incontinence QOL (I-QOL) survey, between and within both arms of the study
Time frame: At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.
Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)
Changes in Neurogenic Bladder Symptom Scores. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms) where a lower score indicates a better outcome.
Time frame: Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.
Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes
Maintaining frequency of catheterization (count per day) and volumes per void (ml per collection)
Time frame: 2 days at the end of each month for 1 year.