Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT02582151
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lawson@lawsonresearch.ca', 'phone': '5196466000', 'title': 'Blayne Welk', 'organization': 'Lawson Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Perception of Bladder Condition Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'OG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurogenic Bladder Symptom Score (NBSS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'OG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '38'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Qualiveen-Short Form Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'OG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '31'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-day Voiding Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'OG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '11'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.', 'unitOfMeasure': 'voids per 24 hrs', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24hr Incontinence Pad Weights', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'OG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'classes': [{'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000', 'lowerLimit': '333', 'upperLimit': '395'}, {'value': '362', 'groupId': 'OG001', 'lowerLimit': '334', 'upperLimit': '391'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'unitOfMeasure': 'grams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physician Assessment of Patient Benefit (Global Response Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'OG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', '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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'FG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Tibial Nerve Stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'BG001', 'title': 'Tibial Nerve Stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.\n\nEV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '60'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '65'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-01', 'size': 108779, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-10T15:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2015-10-13', 'resultsFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Perception of Bladder Condition Questionnaire', 'timeFrame': '3 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Neurogenic Bladder Symptom Score (NBSS) Questionnaire', 'timeFrame': '3 months', '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.'}, {'measure': 'Qualiveen-Short Form Questionnaire', 'timeFrame': '3 months', 'description': 'Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.'}, {'measure': '3-day Voiding Diary', 'timeFrame': '3 months', 'description': 'Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.'}, {'measure': '24hr Incontinence Pad Weights', 'timeFrame': '3 months'}, {'measure': 'Physician Assessment of Patient Benefit (Global Response Scale)', 'timeFrame': '3 months', '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Bladder, Neurogenic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\>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).\n2. Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms.\n\nExclusion Criteria:\n\n1. Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy\n2. Stress predominant urinary incontinence\n3. 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)\n4. Intravesical botulinum toxin use within the last 1 year\n5. Implanted pacemaker or defibrillator\n6. History of epilepsy\n7. Unable or unwilling to commit to study treatment schedule\n8. Pregnant, or possible pregnancy planned for the duration of the study period\n9. Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)\n10. Documented allergy to patch electrodes or their adhesive\n11. Metallic implant within the lower limb"}, 'identificationModule': {'nctId': 'NCT02582151', 'briefTitle': 'Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder', 'orgStudyIdInfo': {'id': '107210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham tibial nerve stimulation', 'description': 'Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.', 'interventionNames': ['Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tibial nerve stimulation', 'description': 'Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.', 'interventionNames': ['Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine']}], 'interventions': [{'name': 'EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine', 'type': 'DEVICE', 'description': 'Percutaneous patch electrodes are used to deliver low level electrical currents.', 'armGroupLabels': ['Sham tibial nerve stimulation', 'Tibial nerve stimulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}