Stroke, Urinary Incontinence
Conditions
Keywords
transcutaneous posterior tibial nerve stimulation, Randomised controlled trial, Feasibility
Brief 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.
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.
Interventions
DEVICENeuroTrac continence stimulators
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.
Sponsors
The Stroke Association, United Kingdom
University of Central Lancashire
Nursing, Midwifery & Allied Health Professions Research Unit
NHS Greater Glasgow and Clyde
NHS Lanarkshire
Glasgow Caledonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of reported episodes of urinary incontinence as a measure of effectiveness. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Up to 16 months | By completion of AUASI |
| 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 | — |
| Changes in the severity of urinary incontinence episodes experienced. | 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 | Up to 16 months | Measured by completion of the Barthel Index Score and Modified Rankin Score. |
| Severity of bowel symptoms | Up to 16 months | — |
Countries
United Kingdom
Outcome results
None listed