Overactive BladderNCT02511717
A Trial of Transcutaneous Nerve Stimulation for OAB
A study testing Transcutaneous tibial nerve stimulation in people with Overactive Bladder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Transcutaneous tibial nerve stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, >18 years of age, with the clinical diagnosis of overactive bladder.
- Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
- Baseline patient perception of bladder condition score of 2 or higher.
Who cannot join
- Current or previous percutaneous 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 12Show 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
- Abnormal sensory function of the lower limb
- Metallic implant within the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients
Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- Transcutaneous tibial nerve stimulation, Sham transcutaneous tibial nerve stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous tibial nerve stimulationOther
Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.
Sham transcutaneous tibial nerve stimulationOther
Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks Receives: Other: Sham transcutaneous tibial nerve stimulation |
| Transcutaneous nerve stimulation | Active comparator | Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks Receives: Other: Transcutaneous tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
Patient percention 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: 12 weeks
Secondary outcomes (4)
Overactive Bladder Questionnaire Short Form (OAB-q SF)
OAB quality of life questionnaire
Measured: 12 weeks
Voiding Diary
Measured: 12 weeks
24hr Pad Weights
Measured: 12 weeks
Physician Assessment of Treatment Benefit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 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 Overactive BladderStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- Principal investigator, Blayne Welk, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511717
- Sponsor's protocol ID
- 106903
- Status last verified
- Oct 2019
- First submitted
- 28 Jul 2015
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients
- ClinicalTrials.gov ID
- NCT02511717
- Acronym / sponsor ID
- 106903
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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
- 30 Jul 2015 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Other: Sham transcutaneous tibial nerve stimulationTranscutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks |
| Transcutaneous nerve stimulation | Active comparator | Other: Transcutaneous tibial nerve stimulationTranscutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female, >18 years of age, with the clinical diagnosis of overactive bladder.
- Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
- Baseline patient perception of bladder condition score of 2 or higher.
Key exclusion criteria (12 listed)
- Current or previous percutaneous 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 |
|---|---|---|
| Transcutaneous tibial nerve stimulationPatch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks. | Other | Transcutaneous nerve stimulation |
| Sham transcutaneous tibial nerve stimulationPatch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks. | Other | Sham |
Primary outcome
Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
Time frame: 12 weeks
Patient percention 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.
4 secondary outcomes
Overactive Bladder Questionnaire Short Form (OAB-q SF)
Time frame: 12 weeks
Voiding Diary
Time frame: 12 weeks
24hr Pad Weights
Time frame: 12 weeks
Physician Assessment of Treatment Benefit
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous tibial nerve stimulation in people with Overactive Bladder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 12 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 23 Oct 2019). 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 Reported Outcome Measure (Patient Percention of Bladder Condition Question) (time frame: 12 weeks). 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 23 Oct 2019.