Randomized,Single-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 3 Days Voiding diary
研究概览
简要总结
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.
详细描述
This experiment is expected to understand the benefits of different settings of electrical stimulation in the treatment of overactive bladder.The study will adopt a longitudinal research design with randomized quasi-experimental trial.The patients will recruited and be randomly assigned to Group A (Parasacral transcutaneous electrical stimulation) or Group B (Intravaginal electrical stimulation). There will be 30 participants in each group. Data will be collected 2 times.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Urinary incontinence due to detrusor overactivity
- •No patients had been taking anticholinergics or tricyclic depressants and none had been treated by pelvic floor exercise, bladder training, or pelvic surgery before entry into the study.
排除标准
- •stress incontinence
- •urinary tract infection
- •neurological disease
- •genital prolapse higher than stage II on POP-Q system
- •pregnancy
- •diabetes mellitus
- •a history of anti-incontinence surgery and/or prolapse repair
- •pelvic tumors and previously treated with radiation therapy or antimuscarinic agents
- •patients who were not cooperative
- •electrical stimulation contraindications
研究组 & 干预措施
Parasacral transcutaneous ES
20min./session, 2 sessions/week ,12 sessions of Parasacral transcutaneous electrical stimulation.
干预措施: Parasacral transcutaneous electrical stimulation (Device)
Intravaginal electrical stimulation
20min./session, 2 sessions/week ,12 sessions of Intravaginal electrical stimulation.
干预措施: Intravaginal electrical stimulation (Device)
结局指标
主要结局
3 Days Voiding diary
时间窗: 3 days
This chart is a record of your voiding and leakage or urine. Choose three (3) separate 24 hour periods to complete this record. Pick days which will be most convenient for you to measure every void.
次要结局
- Overactive Bladder Symptom Score( OABSS）(20 min)
- Pad test(20min-1hr)
- minVisual analogue scale (VAS) for urgency(10 min)
研究者
Yeh
Professor
Chung Shan Medical University