A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Frequency of reported episodes of urinary incontinence as a measure of effectiveness.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Frequency of reported episodes of urinary incontinence as a measure of effectiveness.
时间窗: 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.
次要结局
- 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.(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(Up to 16 months)