Urinary Bladder, NeurogenicNCT02582151
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
A study testing EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine in people with Urinary Bladder, Neurogenic, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Neurogenic
- What is being tested?
- EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Urinary Bladder, Neurogenic
- Being tested
- EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machineDevice
Percutaneous patch electrodes are used to deliver low level electrical currents.
| Study group | Role | What they receive |
|---|---|---|
| Sham tibial nerve stimulation | Sham comparator | Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. Receives: Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine |
| Tibial nerve stimulation | Active comparator | Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. Receives: Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 3 months
3-day Voiding Diary
Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.
Measured: 3 months
24hr Incontinence Pad Weights
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJan 2016
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Bladder, NeurogenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582151
- Sponsor's protocol ID
- 107210
- Status last verified
- Jan 2020
- First submitted
- 13 Oct 2015
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT02582151
- Acronym / sponsor ID
- 107210
- Conditions
- Urinary Bladder, Neurogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tibial nerve stimulation | Sham comparator | Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machineUse of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve. |
| Tibial nerve stimulation | Active comparator | Device: EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machineTranscutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machinePercutaneous patch electrodes are used to deliver low level electrical currents. | Device | Sham tibial nerve stimulation, Tibial nerve stimulation |
Primary outcome
Patient Perception of Bladder Condition Questionnaire
Time frame: 3 months
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.
5 secondary outcomes
Neurogenic Bladder Symptom Score (NBSS) Questionnaire
Time frame: 3 months
Qualiveen-Short Form Questionnaire
Time frame: 3 months
3-day Voiding Diary
Time frame: 3 months
24hr Incontinence Pad Weights
Time frame: 3 months
Physician Assessment of Patient Benefit (Global Response Scale)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine in people with Urinary Bladder, Neurogenic, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Perception of Bladder Condition Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.