A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female

Conditions
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Pelvic Floor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Colpitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum vaginal contraction pressure | it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength | The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation. range(0-5).The higher values represent better outcomes. through vaginal palpation. | 1 day | 
| Pelvic floor muscle strength（repetition） | Levator ani testing is used to quantify PFM strength. range(0-5). The higher values represent better outcomes. | 1 day | 
| Pelvic floor muscle contraction endurance | muscle contractions maintained for 0 s are defined as grade 0, 1 s as grade I, 2 s as grade II, 3 s as grade III, 4 s as grade IV, and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s. range(0-5s). The higher values represent better outcomes. | 1 day | 
| pelvic organ prolapse quantification | POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal. | 1 day | 
| the knack test | a voluntary PFM contraction before or during coughing. That the contraction could be performed represents normal. | 1 day | 
| vaginal rest pressure | measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor muscle strength, Premenopausal nullipara, Childbirth, Postmenopausal