A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
试验速览
- 阶段
- 不适用
- 入组人数
- 7,920
- 试验地点
- 1
- 主要终点
- maximum vaginal contraction pressure
研究概览
简要总结
This study aims to investigate the status of pelvic floor function of healthy female in China, including premenopausal nullipara, premenopausal women with childbirth and postmenopausal women.
详细描述
This is a cross-sectional survey. The normal physical examination population is divided into three groups,including premenopausal nullipara, premenopausal women with childbirth and postmenopausal women. The pelvic floor muscle function in three groups are evaluated. The modified Oxford Grading Scale and Levator ani testing is used to quantify PFM strength through vaginal palpation. Pelvic floor muscle strength ,endurance, repetition,vaginal contraction pressure and the knack test are evaluated using a PHENIX USB 8 neuromuscular stimulation therapy system (Company: Vivaltis-Electronic Concept Lignon Innovation, Montpellier, France). In six different regions of China according to geographic region (northwest, southwest, north, east, northeast, and central-south China) , 1 or more hospitals in each area are selected as sub-centers, which needs to complete the evaluation of pelvic floor muscle function of 360 cases in 3 groups totally.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Group A：Premenopausal women without history of abortion or delivery
- •Having sex life and tolerable to vaginal examination
- •Premenopausal women without history of abortion over 16 weeks
- •Premenopausal women without history of childbirth
- •Planning to live locally for a long time
- •Group B：Premenopausal women with childbirth
- •Having sex life and tolerable to vaginal examination
- •Premenopausal women with childbirth (including cesarean section or natural birth).
- •Planning to live locally for a long time
- •Group C:Postmenopausal women (over a year, except surgical menopause)
- •Having sex life and tolerable to vaginal examination
- •Postmenopausal women
- •Planning to live locally for a long time
排除标准
- •Incontinence 4 weeks before enrollment
- •History of fecal incontinence
- •Prolapse beyond the level of the hymen
- •History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
- •History of pelvic radiotherapy
- •History of pelvic floor surgery
- •History of abortion over 16 weeks' pregnancy or in 1 year after delivery
- •Duration of pregnancy
- •Duration of lactation
- •History of hysterectomy
- •Latex allergy
结局指标
主要结局
maximum vaginal contraction pressure
时间窗: 1 day
it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.
次要结局
- Pelvic floor muscle strength(1 day)
- Pelvic floor muscle contraction endurance(1 day)
- pelvic organ prolapse quantification(1 day)
- the knack test(1 day)
- vaginal rest pressure(1 day)
- Pelvic floor muscle strength（repetition）(1 day)