StrokeTREAT-UINCT02239796
Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
A study testing NeuroTrac continence stimulators in people with Stroke and Urinary Incontinence, run by Glasgow Caledonian University at 2 sites in United Kingdom.
Trial summary
To aim of this study is to establish the feasibility of undertaking a phase III trial of transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate stroke-related urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Urinary Incontinence
- What is being tested?
- NeuroTrac continence stimulators
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men or women aged ≥ 18 years, with a diagnosis of stroke based on the WHO criteria (WHO 1989) and stroke-related urinary incontinence of at least once weekly.
- Onset of stroke ≥ 4 weeks previously and discharged from hospital to own home following a new stroke episode within the previous 6 months.
- Physically, cognitively and communicatively able and willing to learn to apply TPTNS or has carer who is able and willing to learn.
Who cannot join
- Pre-existing urinary incontinence prior to stroke.
- Current Urinary Tract Infection.
- Voiding dysfunction requiring intermittent/indwelling catheterisation.
- Cardiac pacemaker in situ.
- Concurrent neurological diagnosis eg dementia, Multiple Sclerosis, diabetic neuropathy.
- Reduced/absent sensation at electrode placement sites.
- Post-void residual urine volume of > 150ml.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Ayrshire and Arran
Ayrshire
NHS Lanarkshire
Glasgow
About this study
Official title: A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.
To aim of this study is to establish the feasibility of undertaking a phase III trial of transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate stroke-related urinary incontinence.
Read the detailed description
Stroke-related urinary incontinence (UI) persists in more than one third of stroke survivors. It is associated with significant burden including reduced quality of life, increased morbidity and disability. Urgency UI, together with overactive bladder (OAB) symptoms (frequency, urgency, nocturia), is most commonly experienced. Current continence care is limited to lifestyle advice and behavioural interventions such as voiding programmes. There is a reliance on containment approaches and a lack of available options for active treatment. Intermittent electrical stimulation of the posterior tibial nerve (TPTNS) is effective for treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population. This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a programme of TPTNS over a six week period. Bladder function, associated healthcare costs and quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation will be conducted. Pilot RCT and process evaluation results will inform the design of a phase III RCT of TPTNS to treat urinary incontinence in the stroke population.
- Conditions
- Stroke, Urinary Incontinence
- Being tested
- NeuroTrac continence stimulators
- Keywords
- transcutaneous posterior tibial nerve stimulation, Randomised controlled trial, Feasibility
- Medical subject headings
- Stroke, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroTrac continence stimulatorsDevice
Electrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact.
Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators.
NeuroTrac continence stimulatorsDevice
We are using NeuroTrac continence stimulators.
| Study group | Role | What they receive |
|---|---|---|
| TPTNS | Experimental | 12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period using a NeuroTrac continence stimulator.
Two surface electrodes are applied to the non-hemiparetic ankle, where appropriate, or the right ankle where no hemiparesis exists. The electrical stimulator is pre-programmed to safely deliver 30 minutes of continuous stimulation with a pulse frequency of 10 hertz and pulse width 200µs22. The intensity of the current will depend on the stroke survivor's perception threshold and individual comfort and is self-adjusted at each session, but will normally range between 15 and 40 milliamps. Receives: Device: NeuroTrac continence stimulators |
| Sham TPTNS | Sham comparator | The sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks NeuroTrac continence stimulator.
The surface electrodes will be positioned on the lateral malleolar area of the ankle, not the medial aspect, to avoid the posterior tibial nerve.
The stimulation intensity will be increased until sensation is reported, then turned down to 4mA for the 30 minute session, ensuring that despite avoiding the posterior tibial nerve, there is no therapeutic stimulation provided. Receives: Device: NeuroTrac continence stimulators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of reported episodes of urinary incontinence as a measure of effectiveness.
Positive response to International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI SF).
This outcome will be the primary outcome for a future full evaluation trial, should it prove feasible.
Measured: Up to 16 months
Secondary outcomes (11)
Changes in the severity of urinary incontinence episodes experienced.
Measured: Up to 16 months
Number of participants with adverse events as a measure of safety and tolerability.
Measured: Up to 16 months
Changes in severity of urinary urgency, frequency and nocturia.
By completion of AUASI
Measured: Up to 16 months
Urinary symptoms experienced on the American Urological Association Symptom Index
Measured: Up to 16 months
Mean Urgency Perception Scores recorded on a 3 day bladder diary
Measured: Up to 16 months
Patient Perception of Bladder Condition
Measured: Up to 16 months
Severity of bowel symptoms
Measured: Up to 16 months
Patient Perception of Bowel Condition
Measured: up to 16 months
Changes in post-void residual urine volume.
Measured: Up to 16 months
Amount of urine leakage in 24 hours
Measured: Up to 16 months
Participants perception of independence from any help with activities of daily living
Measured by completion of the Barthel Index Score and Modified Rankin Score.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- The Stroke Association, United Kingdom, University of Central Lancashire, Nursing, Midwifery & Allied Health Professions Research Unit, NHS Greater Glasgow and Clyde, NHS Lanarkshire
- Responsible party
- Sponsor
- Investigators
- Joanne Booth, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239796
- Sponsor's protocol ID
- TSA 2013/05
- Acronym
- TREAT-UI
- Status last verified
- Feb 2016
- First submitted
- 12 Aug 2014
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT02239796
- Acronym / sponsor ID
- TREAT-UI / TSA 2013/05
- Conditions
- Stroke, Urinary Incontinence
- Keywords
- transcutaneous posterior tibial nerve stimulation, Randomised controlled trial, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- The Stroke Association, United Kingdom, University of Central Lancashire, Nursing, Midwifery & Allied Health Professions Research Unit, NHS Greater Glasgow and Clyde, NHS Lanarkshire
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To aim of this study is to establish the feasibility of undertaking a phase III trial of transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate stroke-related urinary incontinence.
Detailed description
Stroke-related urinary incontinence (UI) persists in more than one third of stroke survivors. It is associated with significant burden including reduced quality of life, increased morbidity and disability. Urgency UI, together with overactive bladder (OAB) symptoms (frequency, urgency, nocturia), is most commonly experienced. Current continence care is limited to lifestyle advice and behavioural interventions such as voiding programmes. There is a reliance on containment approaches and a lack of available options for active treatment. Intermittent electrical stimulation of the posterior tibial nerve (TPTNS) is effective for treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population. This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a programme of TPTNS over a six week period. Bladder function, associated healthcare costs and quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation will be conducted. Pilot RCT and process evaluation results will inform the design of a phase III RCT of TPTNS to treat urinary incontinence in the stroke population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPTNS | Experimental | Device: NeuroTrac continence stimulators12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period using a NeuroTrac continence stimulator. Two surface electrodes are applied to the non-hemiparetic ankle, where appropriate, or the right ankle where no hemiparesis exists. The electrical stimulator is pre-programmed to safely deliver 30 minutes of continuous stimulation with a pulse frequency of 10 hertz and pulse width 200µs22. The intensity of the current will depend on the stroke survivor's perception threshold and individual comfort and is self-adjusted at each session, but will normally range between 15 and 40 milliamps. |
| Sham TPTNS | Sham comparator | Device: NeuroTrac continence stimulatorsThe sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks NeuroTrac continence stimulator. The surface electrodes will be positioned on the lateral malleolar area of the ankle, not the medial aspect, to avoid the posterior tibial nerve. The stimulation intensity will be increased until sensation is reported, then turned down to 4mA for the 30 minute session, ensuring that despite avoiding the posterior tibial nerve, there is no therapeutic stimulation provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged ≥ 18 years, with a diagnosis of stroke based on the WHO criteria (WHO 1989) and stroke-related urinary incontinence of at least once weekly.
- Onset of stroke ≥ 4 weeks previously and discharged from hospital to own home following a new stroke episode within the previous 6 months.
- Physically, cognitively and communicatively able and willing to learn to apply TPTNS or has carer who is able and willing to learn.
Key exclusion criteria (7 listed)
- Pre-existing urinary incontinence prior to stroke.
- Current Urinary Tract Infection.
- Voiding dysfunction requiring intermittent/indwelling catheterisation.
- Cardiac pacemaker in situ.
- Concurrent neurological diagnosis eg dementia, Multiple Sclerosis, diabetic neuropathy.
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 |
|---|---|---|
| NeuroTrac continence stimulatorsElectrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators. | Device | TPTNS |
| NeuroTrac continence stimulatorsWe are using NeuroTrac continence stimulators. | Device | Sham TPTNS |
Primary outcome
Frequency of reported episodes of urinary incontinence as a measure of effectiveness.
Time frame: Up to 16 months
Positive response to International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI SF). This outcome will be the primary outcome for a future full evaluation trial, should it prove feasible.
11 secondary outcomes
Changes in the severity of urinary incontinence episodes experienced.
Time frame: Up to 16 months
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: Up to 16 months
Changes in severity of urinary urgency, frequency and nocturia.
Time frame: Up to 16 months
Urinary symptoms experienced on the American Urological Association Symptom Index
Time frame: Up to 16 months
Mean Urgency Perception Scores recorded on a 3 day bladder diary
Time frame: Up to 16 months
Patient Perception of Bladder Condition
Time frame: Up to 16 months
Severity of bowel symptoms
Time frame: Up to 16 months
Patient Perception of Bowel Condition
Time frame: up to 16 months
Changes in post-void residual urine volume.
Time frame: Up to 16 months
Amount of urine leakage in 24 hours
Time frame: Up to 16 months
Participants perception of independence from any help with activities of daily living
Time frame: Up to 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
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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.
Joanne Booth principal investigator
Glasgow Caledonian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroTrac continence stimulators in people with Stroke and Urinary Incontinence, run by Glasgow Caledonian University at 2 sites in United Kingdom.
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 7 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of reported episodes of urinary incontinence as a measure of effectiveness. (time frame: Up to 16 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 26 May 2016.