Pelvic Floor
Conditions
Keywords
Pelvic floor muscle strength, Premenopausal nullipara, Childbirth, Postmenopausal
Brief summary
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
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.
Interventions
None listed
Sponsors
Liuzhou Maternity and Child Healthcare Hospital
Qingdao Municipal Hospital
Zhongshan People's Hospital, Guangdong, China
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital of Soochow University
Maternity and Child Health Hospital of Changsha
Henan Provincial People's Hospital
Huaian Maternal and Child Health Care Hospital
Hunan Provincial Maternal and Child Health Care Hospital
The Fourth Hospital of Shijiazhuang
Shenzhen Luohu District Maternity And Child Healthcare Hospital
Second Affiliated Hospital of Wenzhou Medical University
Hubei Shiyan People's Hospital
Changzhi Maternity & Child Health Hospital
Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region
The First Hospital of Hebei Medical University
Shen-Zhen City Maternity and Child Healthcare Hospital
Dalian Medical University
Maternity and Child Care Center of QinHuangDao City
The People's Hospital of Leshan
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Group A：Premenopausal women without history of abortion or delivery 1. Having sex life and tolerable to vaginal examination 2. Premenopausal women without history of abortion over 16 weeks 3. Premenopausal women without history of childbirth 4. Planning to live locally for a long time Group B：Premenopausal women with childbirth 1. Having sex life and tolerable to vaginal examination 2. Premenopausal women with childbirth (including cesarean section or natural birth). 3. Planning to live locally for a long time Group C:Postmenopausal women (over a year, except surgical menopause) 1. Having sex life and tolerable to vaginal examination 2. Postmenopausal women 3. Planning to live locally for a long time
Exclusion criteria
1. Incontinence 4 weeks before enrollment 2. History of fecal incontinence 3. Prolapse beyond the level of the hymen 4. History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect） 5. History of pelvic radiotherapy 6. History of pelvic floor surgery 7. History of abortion over 16 weeks' pregnancy or in 1 year after delivery 8. Duration of pregnancy 9. Duration of lactation 10. History of hysterectomy 11. Latex allergy 12. Colpitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum vaginal contraction pressure | 1 day | it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle strength（repetition） | 1 day | Levator ani testing is used to quantify PFM strength. range(0-5). The higher values represent better outcomes. |
| Pelvic floor muscle contraction endurance | 1 day | 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. |
| Pelvic floor muscle strength | 1 day | 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. |
| the knack test | 1 day | a voluntary PFM contraction before or during coughing. That the contraction could be performed represents normal. |
| vaginal rest pressure | 1 day | measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes. |
| pelvic organ prolapse quantification | 1 day | POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal. |
Countries
China
Contacts
Primary ContactZhijing Sun, MD
Backup ContactLan Zhu, MD
Outcome results
None listed