Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-04-01

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.

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Detailed Description

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Conditions

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Urinary Bladder, Neurogenic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sham tibial nerve stimulation

Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.

Group Type SHAM_COMPARATOR

EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine

Intervention Type DEVICE

Percutaneous patch electrodes are used to deliver low level electrical currents.

Tibial nerve stimulation

Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.

Group Type ACTIVE_COMPARATOR

EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine

Intervention Type DEVICE

Percutaneous patch electrodes are used to deliver low level electrical currents.

Interventions

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EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine

Percutaneous patch electrodes are used to deliver low level electrical currents.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No