A Cross-sectional Study of Female Pelvic Floor Surface Electromyography in Chinese Healthy Female
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- resting amplitude (µV) pre baseline
研究概览
简要总结
This study is a multi-center survey of surface electromyography (sEMG) of pelvic floor muscles in healthy female. The aim of the study is to get the reference interval of normal pelvic floor sEMG from Chinese women.
详细描述
Pelvic floor dysfunction is a group of diseases caused by the damage of pelvic floor supporting structure. Pelvic floor muscles play an important role in the maintenance of pelvic floor function. Surface electromyography (sEMG) has been widely used to evaluate the function of pelvic floor muscles. The sEMG tests, which include pretest and posttest resting amplitude (µV), as well as phasic, tonic and endurance contractile amplitude (µV), are performed using Vishee neuro-muscle stimulator (MyoTrac Infiniti, model SA9800, Thought Technology Ltd., Montreal, Canada), following the Glazer protocols. A pear-shaped vaginal probe (serial number DYS180610, type VET-A, produced by Nanjing Vishee Medical Technology, Ltd.) is placed into the vagina when sEMG tests are performed. This is a cross-sectional survey. The reference intervals of pelvic floor sEMG in healthy female are evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a. Having sex life and tolerable to vaginal examination b. There were no symptoms related to pelvic floor dysfunction; c. The modified Oxford grading system was 4 or 5; d. No birth or 2 years after the last delivery;
排除标准
- •a. Duration of pregnancy and lactation; b. Within 2 years after delivery; c. Acute inflammation of vagina or discomfort of vagina; d. History of pelvic floor dysfunction: leakage of urine in the past 1 month when coughing / sneezing / lifting; leakage of urine in the past 1 month when urgency fecal incontinence in the past 1 month; usually have a bulge or something falling out that can be seen or felt in vaginal area; Pain in the abdomen or lumbosacral and buttocks below the navel for more than 6 months; e. History of radical pelvic surgery (cervical cancer, rectal cancer, bladder cancer, etc.); f. History of hysterectomy and subtotal hysterectomy; g. History of pelvic floor surgery (anti-incontinence and prolapse surgery); h. History of pelvic radiotherapy; i. Nervous system diseases that significantly affect muscle function; j. Those who can't cooperate with pelvic floor contraction
结局指标
主要结局
resting amplitude (µV) pre baseline
时间窗: 1 day
pretest one minute rest
次要结局
- recovery time at termination of rapid contraction(second)(1 day)
- coefficients of variability for the tonic contraction(1 day)
- average amplitude of tonic contraction(µV)(1 day)
- coefficients of variability pre baseline(1 day)
- maximum rapid contraction amplitude (µV)(1 day)
- recovery time at termination of tonic contraction(second)(1 day)
- coefficients of variability post baseline(1 day)
- average amplitude of endurance contraction(µV)(1 day)
- coefficients of variability for the endurance contraction(1 day)
- resting amplitude (µV) post baseline(1 day)