Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence "TREAT-UI"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • NeuroTrac continence stimulators Device
    Intervention Desc: We are using NeuroTrac continence stimulators.
    ARM 1: Kind: Experimental
    Label: Transcutaneous posterior tibial nerve stimulation
    Description: 12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period. 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.
    ARM 2: Kind: Experimental
    Label: Sham transcutaneous posterior tibial nerve stimulation
    Description: The sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks. 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.
    ARM 3: Kind: Experimental
    Label: TPTNS
    Description: 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.
    ARM 4: Kind: Experimental
    Label: Sham TPTNS
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Frequency of reported episodes of urinary incontinence as a measure of effectiveness. Up to 16 months No
Secondary Changes in the severity of urinary incontinence episodes experienced. Up to 16 months No
Secondary Number of participants with adverse events as a measure of safety and tolerability. Up to 16 months Yes
Secondary Changes in severity of urinary urgency, frequency and nocturia. Up to 16 months No
Secondary Urinary symptoms experienced on the American Urological Association Symptom Index Up to 16 months No
Secondary Mean Urgency Perception Scores recorded on a 3 day bladder diary Up to 16 months No
Secondary Patient Perception of Bladder Condition Up to 16 months No
Secondary Severity of bowel symptoms Up to 16 months No
Secondary Patient Perception of Bowel Condition up to 16 months No
Secondary Changes in Barthel Index Score Up to 16 months No
Secondary Changes in Modified Rankin Score up to 16 months No
Secondary Changes in post-void residual urine volume. Up to 16 months No
Secondary Amount of urine leakage in 24 hours Up to 16 months No
Secondary Participants perception of independence from any help with activities of daily living Up to 16 months No

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