Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

Study Overview
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Brief Summary
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Neurogenic bladder patients may have symptoms of urinary frequency, urgency, urgency incontinence and voiding symptoms due to bladder dysfunction arising from their underlying neurologic condition. Current treatment options are effective for some patients, however many patients are not optimally managed due to modest efficacy or significant side effects. Second line therapies include intravesical onabotulinum toxin, however it is associated with a risk of urinary retention, and patients with neurologic disorders often are unable to perform self catheterize due to physical limitations. Sacral neuromodulation is associated with an undesirably high cost and potential complications in this population. The use of transcutaneous tibial nerve stimulation is an alternative form of neuromodulation, and it may have some potential benefits over percutaneous tibial nerve stimulation. While some preliminary studies have suggested it may be effective, there are no high quality randomized trials. This proposal is a 3 month, randomized, sham-controlled, clinical trial to evaluate the short term clinical efficacy of at home transcutaneous tibial nerve stimulation. Valid and reliable patient reported outcome measures, and objective measures of incontinence have been included as outcomes.

Official Title
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A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder

Conditions
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Urinary Bladder, Neurogenic

Intervention / Treatment
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* Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age, with a clinical condition associated with neurogenic bladder dysfunction (multiple sclerosis, Parkinson's disease, stroke, dementia, cerebral palsy, spinal cord injury)(27). Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms. Exclusion Criteria: Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy Stress predominant urinary incontinence Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron) Intravesical botulinum toxin use within the last 1 year Implanted pacemaker or defibrillator History of epilepsy Unable or unwilling to commit to study treatment schedule Pregnant, or possible pregnancy planned for the duration of the study period Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma) Documented allergy to patch electrodes or their adhesive Metallic implant within the lower limb

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham tibial nerve stimulation<br>Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. | Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine<br>* Percutaneous patch electrodes are used to deliver low level electrical currents.<br>|
| Active Comparator: Tibial nerve stimulation<br>Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. | Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine<br>* Percutaneous patch electrodes are used to deliver low level electrical currents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Perception of Bladder Condition Questionnaire | Patient perception of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurogenic Bladder Symptom Score (NBSS) Questionnaire | The NBSS is a patient reported symptom score covering three domains: incontinence, storage/voiding, and consequences. It is scored from 0 to 72, and a higher score is worse outcome. | 3 months | 
| Qualiveen-Short Form Questionnaire | Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse. | 3 months | 
| 3-day Voiding Diary | Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency. | 3 months | 
| 24hr Incontinence Pad Weights |  | 3 months | 
| Physician Assessment of Patient Benefit (Global Response Scale) | Completed by physicians based on their assessment after discussion with the patient as to the amount of benefit they received. Reported on a scale of 0 (no benefit) to 7 (substantial benefit) | 3 months |