Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home

Official Title
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Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

Conditions
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Chronic Spinal Cord Injury, Neurogenic Bladder

Intervention / Treatment
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* Device: High Dose
* Device: Low dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic and non-traumatic SCI performing IC Up to 2 anticholinergic overactive bladder (OAB) medications No changes in OAB medications Neurologic level of injury above T10 English and Spanish speaking Exclusion Criteria: Past history of genitourinary diagnoses or surgeries History of central nervous system (CNS) disorders and/or peripheral neuropathy Pregnancy Lower motor neuron bladder Concern for tibial nerve pathway injury Absence of toe flexion or AD with electric stimulation Bladder chemodenervation in past 6 months Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized sham-control trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose<br> | Device: High Dose<br>* 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 the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.<br>* Other names: TTNS stimulation;|
| Other: Control<br>Low dose TTNS | Device: Low dose<br>* Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes<br>* Other names: TTNS stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduction in bladder medication |  | 3 months after subject enrollment | 
| Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the neurogenic bladder symptom score (NBSS)scale. | The NBSS scale consists of 24 questions each with a score ranging form 0-4.Higher the score indicates a worse outcome. | 3 months after subject enrollment | 
| Number of participants with reduced neurogenic bladder symptoms (NGB) as measured by the voiding dairy |  | 3 months after subject enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with improved quality of life as assessed by the I-QOL questionnaire |  | 3 months after subject enrollment | 
| Number of participants with decreased anticholinergic side effects as measured by the anticholinergic side effects survey |  | 3 months after subject enrollment | 
| Number of participants with stable or improved bladder capacity as assessed by the urodynamic study | urodynamic study | At baseline and 3 month after subject enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electric stimulation