Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
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.
Inclusion Criteria:

 1. >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).

 2. Failure of behavioral measures and/or pharmacologic therapy to adequately control
 neurogenic bladder symptoms.

 Exclusion Criteria:

 1. Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral
 neuromodulation therapy

 2. Stress predominant urinary incontinence

 3. 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)

 4. Intravesical botulinum toxin use within the last 1 year

 5. Implanted pacemaker or defibrillator

 6. History of epilepsy

 7. Unable or unwilling to commit to study treatment schedule

 8. Pregnant, or possible pregnancy planned for the duration of the study period

 9. Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)

 10. Documented allergy to patch electrodes or their adhesive

 11. Metallic implant within the lower limb