Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

Not Applicable

Completed

• Conditions: Urinary Bladder, Neurogenic
• Interventions: Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine

• Registration Number: NCT02582151
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Study Start: 2016-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-01
• Results First Submitted: 2019-09-11
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Results First Posted: 2020-01-09
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tibial nerve stimulation	EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine	Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
Tibial nerve stimulation	EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine	Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.

Primary Outcome Measures

Name	Time	Method
Patient Perception of Bladder Condition Questionnaire	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Neurogenic Bladder Symptom Score (NBSS) Questionnaire	3 months	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.
24hr Incontinence Pad Weights	3 months
Physician Assessment of Patient Benefit (Global Response Scale)	3 months	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)
Qualiveen-Short Form Questionnaire	3 months	Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.
3-day Voiding Diary	3 months	Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.