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

Pelvic Floor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03516266
• Other study ID #: JS-1550
• Status: Recruiting
• Start date: May 10, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Peking Union Medical College Hospital
• Contact: Zhijing Sun, MD
• Phone: 13651314354
• Email: sunzhj2001[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7920
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Beijing	Beiing

Sponsors (22)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Changzhi Maternity and Child Health Hospital, Dalian Gynaecology and Obstetrics Hospital, Dalian Municipal Women and Children's Medical Center, Fourth Hospital of Shijiazhuang City, Henan Provincial Hospital, Huaian Maternal and Child Health Care Hospital, Hubei Shiyan People's Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Liuzhou Maternity and Child Healthcare Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, Maternity and Child Care Center of QinHuangDao City, Maternity and Child Health Hospital of Changsha, Qingdao Municipal Hospital, Second Affiliated Hospital of Soochow University, Second Affiliated Hospital of Wenzhou Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Shenzhen Luohu District Maternity And Child Healthcare Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Hebei Medical University, The People's Hospital of Leshan, Zhongshan City People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum vaginal contraction pressure	it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.	1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	pelvic organ prolapse quantification	POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal.	1 day
Secondary	the knack test	a voluntary PFM contraction before or during coughing. That the contraction could be performed represents normal.	1 day
Secondary	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