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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pelvic Floor

Study type: Observational

Funder types: Other

Identifiers

NCT03516266

JS-1550

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,920 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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