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

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ClinicalTrials.gov Identifier: NCT03516266

Recruitment Status : Unknown

Verified April 2018 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting

First Posted : May 4, 2018

Last Update Posted : May 11, 2018

Sponsor:

Collaborators:

Liuzhou Maternity and Child Healthcare Hospital

Qingdao Municipal Hospital

Zhongshan City People's Hospital

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

Fourth Hospital of Shijiazhuang City

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

Information provided by (Responsible Party):

Peking Union Medical College Hospital

Study Description

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.

Condition or disease
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 Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	7920 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Target Follow-Up Duration:	1 Day
Official Title:	A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
Actual Study Start Date :	May 10, 2018
Estimated Primary Completion Date :	December 31, 2020
Estimated Study Completion Date :	December 31, 2020

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Pelvic floor muscle strength [ Time Frame: 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 strength（repetition） [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 day ]
POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal.
the knack test [ Time Frame: 1 day ]
a voluntary PFM contraction before or during coughing. That the contraction could be performed represents normal.
vaginal rest pressure [ Time Frame: 1 day ]
measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
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).

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516266

Contacts

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Contact: Zhijing Sun, MD	13651314354	sunzhj2001@sina.com
Contact: Lan Zhu, MD		zhu_julie@vip.sina.com

Locations

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China, Beiing
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Recruiting
Beijing, Beiing, China, 100730
Contact: Zhijing Sun, MD 13651314354 sunzhj2001@sina.com

Sponsors and Collaborators