Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overactive bladder symptoms severity
研究概览
简要总结
Neurogenic overactive bladder (nOAB) is a common and distressing sequela following stroke, significantly impairing quality of life and imposing a substantial financial burden. Existing pharmacological options often present adverse effects, while standard non-pharmacological treatments, such as pelvic floor muscle training (PFMT), face compliance and efficacy limitations in individuals with functional impairments. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique capable of modulating neuronal excitability and cortical plasticity. Targeting the supplementary motor area (SMA) via tDCS may regulate pelvic floor muscle (PFM) and detrusor activities. However, clinical evidence evaluating tDCS as an adjuvant to PFMT for stroke survivors with nOAB is lacking. This randomized controlled pilot trial aims to evaluate the feasibility, preliminary effectiveness, and cost-utility of active tDCS combined with PFMT compared to sham tDCS plus PFMT in stroke survivors suffering from nOAB.
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, Outcomes Assessor)
盲法说明
The allocation of the participants will be sealed in an envelope, blinding the participants and assessors, and a third person (intervention implementer) will perform the blinding.
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
- •Aged between 18-80 years with onset of stroke within one and twelve months of enrollment and having overactive bladder (OAB) symptoms;
- •Experiencing moderate (scoring 6-11 points on the Overactive Bladder Symptom Score [OABSS]) to severe OAB (scoring ≥ 12 points on OABSS);
- •Obtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
排除标准
- •Presence of metallic implants in the cranium, intracardiac lines, increased intracranial pressure, cardiac pacemaker, cochlear implants, tumour, and skull abnormalities;
- •Family history of epilepsy/seizures;
- •Contraindications to transcranial magnetic stimulation.
研究组 & 干预措施
Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
干预措施: Active transcranial direct current stimulation (tDCS) (Device)
Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
干预措施: Pelvic floor muscle training (PFMT) (Behavioral)
Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
干预措施: Sham transcranial direct current stimulation (tDCS) (Device)
Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
干预措施: Pelvic floor muscle training (PFMT) (Behavioral)
结局指标
主要结局
Overactive bladder symptoms severity
时间窗: Baseline and post-intervention at 8 weeks
Overactive bladder symptoms severity will be assessed using Overactive Bladder Symptom Score (OABSS). The total score of OABSS ranges from 0 to 15, with a higher score indicating higher symptom severity.
次要结局
- Recruitment Rate(Through study completion, an average of 1 year.)
- Time to Complete Recruitment(Through study completion, an average of 1 year.)
- Retention Rate(Baseline to 8 weeks)
- Adherence to Intervention(Baseline to 8 weeks)
- Adverse Events(Baseline to 8 weeks)
- Detrusor Wall Thickness(Baseline and post-intervention at 8 weeks)
- Bladder Neck Elevation(Baseline and post-intervention at 8 weeks)
- Health-Related Quality of Life(Baseline and post-intervention at 8 weeks)
- Healthcare Costs(Baseline and post-intervention at 8 weeks.)
- Incontinence-related quality of life(Baseline and post-intervention at 8 weeks)
研究者
Dr. Priya Kannan
Associate Professor
The Hong Kong Polytechnic University