Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.

Conditions
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Stroke, Urinary Incontinence

Intervention / Treatment
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* Device: NeuroTrac continence stimulators
* Device: NeuroTrac continence stimulators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPTNS<br>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. | Device: NeuroTrac continence stimulators<br>* 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.<br>|
| Sham Comparator: Sham TPTNS<br>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. | Device: NeuroTrac continence stimulators<br>* We are using NeuroTrac continence stimulators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the severity of urinary incontinence episodes experienced. |  | Up to 16 months | 
| Number of participants with adverse events as a measure of safety and tolerability. |  | Up to 16 months | 
| Changes in severity of urinary urgency, frequency and nocturia. | By completion of AUASI | Up to 16 months | 
| Urinary symptoms experienced on the American Urological Association Symptom Index |  | Up to 16 months | 
| Mean Urgency Perception Scores recorded on a 3 day bladder diary |  | Up to 16 months | 
| Patient Perception of Bladder Condition |  | Up to 16 months | 
| Severity of bowel symptoms |  | Up to 16 months | 
| Patient Perception of Bowel Condition |  | up to 16 months | 
| Changes in post-void residual urine volume. |  | Up to 16 months | 
| Amount of urine leakage in 24 hours |  | 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. | Up to 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised controlled trial, transcutaneous posterior tibial nerve stimulation, Feasibility