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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Floor

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.

• Study Type: Observational
• Enrollment (Anticipated): 7920

Contacts and Locations

Study Locations

• China
  • Beiing
    • Beijing, Beiing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Volunteers are divided into three groups, and each clinical center requires at least 120 persons in each group.

Group A: Premenopausal women without history of abortion or delivery.

Group B: Premenopausal women with childbirth (including cesarean section or natural birth).

Group C:Postmenopausal women (except surgical menopause).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Qingdao Municipal Hospital; Henan Provincial People's Hospital; Second Affiliated Hospital of Wenzhou Medical University; Second Affiliated Hospital of Soochow University; The First Hospital of Hebei Medical University; Fourth Hospital of Shijiazhuang City; Zhongshan People's Hospital, Guangdong, China; Shen-Zhen City Maternity and Child Healthcare Hospital; Liuzhou Maternity and Child Healthcare Hospital; Maternity and Child Health Hospital of Changsha; Huaian Maternal and Child Health Care Hospital; Hunan Provincial Maternal and Child Health Care Hospital; Shenzhen Luohu District Maternity And Child Healthcare Hospital; Hubei Shiyan People's Hospital; Changzhi Maternity & Child Health Hospital; Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region; Dalian Medical University; Maternity and Child Care Center of QinHuangDao City; The People's Hospital of Leshan

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2018
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (ACTUAL): May 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Childbirth; Postmenopausal; Pelvic floor muscle strength; Premenopausal nullipara
• Other Study ID Numbers: JS-1550

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No