A Mixed-methods Evaluation of the Clinical and Cost-effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neurogenic Overactive Bladder in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overactive bladder symptom score (OABSS) questionnaire.
研究概览
简要总结
Neurogenic overactive bladder (NOAB) presents with urgency incontinence. Existing NOAB management is expensive, lacks standardized regimens, or is invasive. Therefore, evaluating the effectiveness of non-invasive repetitive transcranial magnetic stimulation (rTMS) for NOAB management among stroke survivors remains crucial.
Objectives: Evaluate the effects of active-rTMS compared to sham-rTMS among stroke survivors with NOAB, the interventions' cost-effectiveness and explore their experiences qualitatively.
详细描述
Summary Background: Neurogenic overactive bladder (NOAB) presents with urgency incontinence. Existing NOAB management is expensive, lacks standardized regimens, or is invasive. Therefore, evaluating the effectiveness of non-invasive repetitive transcranial magnetic stimulation (rTMS) for NOAB management among stroke survivors remains crucial.
Objectives: Evaluate the effects of active-rTMS compared to sham-rTMS among stroke survivors with NOAB, the interventions' cost-effectiveness and explore their experiences qualitatively.
Hypothesis
Active-rTMS will reduce NOAB symptom severity for stroke survivors, interventions' cost and assist in gaining insight into the NOAB patients' experiences.
Methods: This study will be a randomised-sham-controlled, double-blinded trial, with embedded qualitative and cost-effectiveness studies. Snowball-convenience sampling technique and computer-generated randomisation will be adopted to recruit 30 participants into active-rTMS and sham-rTMS groups each. Active-rTMS participants will receive a continuous 1 pulse per second 1200 pulses of low-frequency rTMS to the pelvic floor muscle representation in the contralesional primary motor cortex (M1) for 20 minutes thrice weekly. Sham-rTMS participants will receive the same parameters as the active-rTMS group, however, the coil will be rotated 90° away from the scalp. Fifteen active-rTMS participants will be invited for 45-60 minutes focus group discussions. The primary and secondary outcomes will be urinary incontinence severity and quality of life evaluated using the Overactive Bladder Symptom Score and Incontinence-Quality of life Questionnaire, respectively. Quality-adjusted life-years (QALY) will be the cost-effectiveness outcome. The EQ-5D-5L responses will estimate the gain or loss of QALY. A follow-up assessment will be conducted one-months post-intervention. The Client Service Receipt Inventory (CSRI) will be used to collect information on the whole range of services and support required by the study participants.
Statistical analysis
Normality will be evaluated using Shapiro-Wilk test. To determine active-rTMS and sham-rTMS group differences, between-groups analysis of covariance (ANCOVA) will be conducted using R software. Bonferroni correction will be applied for multiple comparisons. Thematic analysis will be used for analysing the qualitative data. For the cost-effectiveness analysis, the unadjusted mean costs and cost differences between active-rTMS and the sham-rTMS group will be calculated.
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
- Double (Participant, Care Provider)
盲法说明
The therapist and the participants will be blinded in the recruitment, randomization and treatment allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke survivors aged between 18-80 years diagnosed with NOAB
- •Urodynamic findings confirming detrusor overactivity
- •Experience moderate (OABSS scores: 6-11 points) to severe NOAB (OABSS scores: 12 points and above)
- •Obtain a Mini-Mental State Examination (MMSE) score of ≥ 24
- •Be willing to be randomized
排除标准
- •Presence of metals in the cranium, intracardiac lines, increased intracranial pressure, heart diseases, or cardiac pacemaker, use of sacral neuro-modulation
- •Pregnancy or less than six months postpartum stage
- •Patients with a family history of epilepsy or seizures
- •Patients taking tricyclic antidepressants or neuroepileptics
- •Participation in any other research project related to urinary incontinence; contra-indicated to MRI, urologic cancer, prostatic pathology, severe pelvic pain, six weeks post-surgery and non-neurogenic bladder
结局指标
主要结局
Overactive bladder symptom score (OABSS) questionnaire.
时间窗: Pre intervention, post intervention (4 weeks) and follow up (4 weeks)
The OABSS is reported to be a reliable and valid questionnaire for the quantitative evaluation of overactive bladder symptoms in the Hong Kong population (ICC score: 0.82). The measure comprised four questions on OAB symptoms with domain maximum scores ranging from 2 to 5: daytime frequency (two points), night-time frequency (three points), urgency (five points), and UUI (five points). The OABSS total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. According to severity, mild is defined as a score of 3 to 5 points, moderate as a score of 6 to 11 points, and severe as a score of 12 or more points.
次要结局
- Incontinence Quality-of-Life Questionnaire (I-QoL)(Pre intervention, post intervention (4 weeks) and follow up (4 weeks))
- The Brief Resilience Scale(Pre intervention, post intervention (4 weeks) and follow up (4 weeks))
- The 5-level EQ-5D (EQ-5D-5L)(Pre intervention, post intervention (4 weeks) and follow up (4 weeks))