Clinical trial NCT02582151: Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
Official title: A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Neurogenic
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Perception of Bladder Condition Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Neurogenic Bladder Symptom Score (NBSS) Questionnaire
timeFrame: 3 months
measure: Qualiveen-Short Form Questionnaire
timeFrame: 3 months
measure: 3-day Voiding Diary
timeFrame: 3 months
measure: 24hr Incontinence Pad Weights
timeFrame: 3 months
measure: Physician Assessment of Patient Benefit (Global Response Scale)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: