Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

A Randomized Trial of Transcutaneous Nerve Stimulation 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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Neurogenic
• Intervention / Treatment: Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham tibial nerve stimulation; 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; Percutaneous patch electrodes are used to deliver low level electrical currents.
Active Comparator: Tibial nerve stimulation; Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.	Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine; Percutaneous patch electrodes are used to deliver low level electrical currents.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 107210