Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Movement of the Bladder
研究概览
简要总结
Subjects will place a surface electrode on their perineal area after a bladder-filling protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic floor contraction and electrical stimulation active.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
The patient was not allowed to see the ultrasound screen
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age:18-80y
- •Gender: female
排除标准
- •Moderate-severe stress incontinence*: As determined by self-reported >3 accidents in 24-hr period
- •Currently pregnant, may be pregnant (Unsure pre and peri-menopausal women should take a pregnancy test.)
- •Active urinary tract infection (UTI)
- •Pelvic pain, Painful bladder syndrome, underlying neurologic/neuromuscular disorder that may impact ability to partake in the trial
- •implanted cardiac device or untreated cardiac arrhythmia
- •Obesity as defined by BMI >= 30 (height, weight recorded)
- •Anyone with impaired decision making, drug or alcohol dependence, or potentially suicidal.
- •Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent * Stress urinary incontinence: as determined by an answer of "Yes" to a standard question (from King's Health Questionnaire): "Do you lose urine with physical activities such as coughing, sneezing, running?"
研究组 & 干预措施
Surface electrical stimulation
Each subject did a Kegel pelvic floor contraction, had the surface electrical stimulation turned on at highest comfortable intensity, did a Kegel contraction with surface electrical stimulation on, and had second electrical stimulation turned on.
干预措施: Surface electrical stimulation (Device)
结局指标
主要结局
Movement of the Bladder
时间窗: 1 Day
Visualization of movement of the bladder with use of device by transabdominal ultrasound was captured and the measurement is measured in pixels for centroid magnitude displacement.
次要结局
未报告次要终点