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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham tibial nerve stimulation | Sham Comparator | Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. |
|
| Tibial nerve stimulation | Active Comparator | Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine | Device | Percutaneous patch electrodes are used to deliver low level electrical currents. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Tibial Nerve Stimulation | Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents. |
| FG001 | Tibial Nerve Stimulation | Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Tibial Nerve Stimulation | Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Tibial Nerve Stimulation | Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blayne Welk | Lawson Health Research | 5196466000 | lawson@lawsonresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Sep 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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 |
| Tibial Nerve Stimulation |
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Units on a scale | 3 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
| Secondary | 3-day Voiding Diary | Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency. | Posted | Median | Inter-Quartile Range | voids per 24 hrs | 3 months |
|
|
|
| Secondary | 24hr Incontinence Pad Weights | Posted | Median | Inter-Quartile Range | grams | 3 months |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Tibial Nerve Stimulation | Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |