Clinical trial NCT03516266: A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
Official title: A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor
Keywords: Pelvic floor muscle strength
Premenopausal nullipara
Childbirth
Postmenopausal
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Liuzhou Maternity and Child Healthcare Hospital
name: Qingdao Municipal Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital of Soochow University
name: Maternity and Child Health Hospital of Changsha
name: Henan Provincial People's Hospital
name: Huaian Maternal and Child Health Care Hospital
name: Hunan Provincial Maternal and Child Health Care Hospital
name: Fourth Hospital of Shijiazhuang City
name: Shenzhen Luohu District Maternity And Child Healthcare Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Hubei Shiyan People's Hospital
name: Changzhi Maternity & Child Health Hospital
name: Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region
name: The First Hospital of Hebei Medical University
name: Shen-Zhen City Maternity and Child Healthcare Hospital
name: Dalian Medical University
name: Maternity and Child Care Center of QinHuangDao City
name: The People's Hospital of Leshan
First posted: 2018-05-04
Enrollment: 7920
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: maximum vaginal contraction pressure
timeFrame: 1 day
Secondary outcomes:
measure: Pelvic floor muscle strength
timeFrame: 1 day
measure: Pelvic floor muscle strength（repetition）
timeFrame: 1 day
measure: Pelvic floor muscle contraction endurance
timeFrame: 1 day
measure: pelvic organ prolapse quantification
timeFrame: 1 day
measure: the knack test
timeFrame: 1 day
measure: vaginal rest pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
state: Beiing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: