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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
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.
We are using NeuroTrac continence stimulators.
NHS Ayrshire and Arran
Ayrshire, United Kingdom
NHS Lanarkshire
Glasgow, United Kingdom
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.
Time frame: Up to 16 months
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.
By completion of AUASI
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.
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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
Measured by completion of the Barthel Index Score and Modified Rankin Score.
Time frame: Up to 16 months