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

• Conditions: Pelvic Floor

• Registration Number: NCT03516266
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-04
• Study Start: 2018-05-10
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 7920

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maximum vaginal contraction pressure	1 day	it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.

Secondary Outcome Measures

Name	Time	Method
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.
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 organ prolapse quantification	1 day	POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal.
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 floor muscle strength（repetition）	1 day	Levator ani testing is used to quantify PFM strength. range(0-5). The higher values represent better outcomes.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences; 🇨🇳 Beijing, Beiing, China