Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
Primary Purpose
Urinary Bladder, Neurogenic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Neurogenic
Eligibility Criteria
Inclusion Criteria:
- >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).
- Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms.
Exclusion Criteria:
- Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy
- Stress predominant urinary incontinence
- 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)
- Intravesical botulinum toxin use within the last 1 year
- Implanted pacemaker or defibrillator
- History of epilepsy
- Unable or unwilling to commit to study treatment schedule
- Pregnant, or possible pregnancy planned for the duration of the study period
- Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
- Documented allergy to patch electrodes or their adhesive
- Metallic implant within the lower limb
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham tibial nerve stimulation
Tibial nerve stimulation
Arm Description
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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-day Voiding Diary
Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.
24hr Incontinence Pad Weights
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)
Full Information
NCT ID
NCT02582151
First Posted
October 13, 2015
Last Updated
January 6, 2020
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02582151
Brief Title
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
Official Title
A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Neurogenic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham tibial nerve stimulation
Arm Type
Sham Comparator
Arm Description
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
Arm Title
Tibial nerve stimulation
Arm Type
Active Comparator
Arm Description
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
Intervention Type
Device
Intervention Name(s)
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine
Intervention Description
Percutaneous patch electrodes are used to deliver low level electrical currents.
Primary Outcome Measure Information:
Title
Patient Perception of Bladder Condition Questionnaire
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neurogenic Bladder Symptom Score (NBSS) Questionnaire
Description
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.
Time Frame
3 months
Title
Qualiveen-Short Form Questionnaire
Description
Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.
Time Frame
3 months
Title
3-day Voiding Diary
Description
Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.
Time Frame
3 months
Title
24hr Incontinence Pad Weights
Time Frame
3 months
Title
Physician Assessment of Patient Benefit (Global Response Scale)
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>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).
Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms.
Exclusion Criteria:
Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy
Stress predominant urinary incontinence
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)
Intravesical botulinum toxin use within the last 1 year
Implanted pacemaker or defibrillator
History of epilepsy
Unable or unwilling to commit to study treatment schedule
Pregnant, or possible pregnancy planned for the duration of the study period
Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
Documented allergy to patch electrodes or their adhesive
Metallic implant within the lower limb
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
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