Clinical trial NCT04245137: Reference Intervals of the sEMG of the Pelvic Floor in Healthy Female
Official title: A Cross-sectional Study of Female Pelvic Floor Surface Electromyography in Chinese Healthy Female
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Xi'an People's Hospital (Xi'an Fourth Hospital)
name: Maternal and Child Health Hospital of Anhui Province
name: Ningbo Women & Children's Hospital
name: Gansu Province Maternal and Child Care Hospital
name: Foshan Maternity and Child Health Care Hospital
First posted: 2020-01-28
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy females with no symptoms of pelvic floor dysfunciton and normal contraciton strength, and at least 2 yrs postpartum.

Brief summary: This study is a multi-center survey of surface electromyography (sEMG) of pelvic floor muscles in healthy female. The aim of the study is to get the reference interval of normal pelvic floor sEMG from Chinese women.

Detailed description: Pelvic floor dysfunction is a group of diseases caused by the damage of pelvic floor supporting structure. Pelvic floor muscles play an important role in the maintenance of pelvic floor function. Surface electromyography (sEMG) has been widely used to evaluate the function of pelvic floor muscles. The sEMG tests, which include pretest and posttest resting amplitude (µV), as well as phasic, tonic and endurance contractile amplitude (µV), are performed using Vishee neuro-muscle stimulator (MyoTrac Infiniti, model SA9800, Thought Technology Ltd., Montreal, Canada), following the Glazer protocols. A pear-shaped vaginal probe (serial number DYS180610, type VET-A, produced by Nanjing Vishee Medical Technology, Ltd.) is placed into the vagina when sEMG tests are performed. This is a cross-sectional survey. The reference intervals of pelvic floor sEMG in healthy female are evaluated.

Eligibility criteria: Inclusion Criteria:

* a. Having sex life and tolerable to vaginal examination b. There were no symptoms related to pelvic floor dysfunction; c. The modified Oxford grading system was 4 or 5; d. No birth or 2 years after the last delivery;

Exclusion Criteria:

* a. Duration of pregnancy and lactation; b. Within 2 years after delivery; c. Acute inflammation of vagina or discomfort of vagina; d. History of pelvic floor dysfunction: leakage of urine in the past 1 month when coughing / sneezing / lifting; leakage of urine in the past 1 month when urgency fecal incontinence in the past 1 month; usually have a bulge or something falling out that can be seen or felt in vaginal area; Pain in the abdomen or lumbosacral and buttocks below the navel for more than 6 months; e. History of radical pelvic surgery (cervical cancer, rectal cancer, bladder cancer, etc.); f. History of hysterectomy and subtotal hysterectomy; g. History of pelvic floor surgery (anti-incontinence and prolapse surgery); h. History of pelvic radiotherapy; i. Nervous system diseases that significantly affect muscle function; j. Those who can't cooperate with pelvic floor contraction

Primary outcomes:
measure: resting amplitude (µV) pre baseline
timeFrame: 1 day
Secondary outcomes:
measure: coefficients of variability pre baseline
timeFrame: 1 day
measure: maximum rapid contraction amplitude (µV)
timeFrame: 1 day
measure: recovery time at termination of rapid contraction(second)
timeFrame: 1 day
measure: average amplitude of tonic contraction(µV)
timeFrame: 1 day
measure: coefficients of variability for the tonic contraction
timeFrame: 1 day
measure: recovery time at termination of tonic contraction(second)
timeFrame: 1 day
measure: average amplitude of endurance contraction(µV)
timeFrame: 1 day
measure: coefficients of variability for the endurance contraction
timeFrame: 1 day
measure: resting amplitude (µV) post baseline
timeFrame: 1 day
measure: coefficients of variability post baseline
timeFrame: 1 day
Other outcomes:
Locations:
city: Hefei
country: China
facility: Maternal and Child Health Hospital of Anhui Province
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science
state: Beijing
city: Lanzhou
country: China
facility: Gansu Province Maternal and Child Care Hospital
state: Gansu
city: Foshan
country: China
facility: Foshan Maternal and Child Health Care Hospital
state: Guangdong
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an' Fourth Hospital
state: Shanxi
city: Ningbo
country: China
facility: Ningbo Women & Children's Hospital
state: Zhejiang
Study officials:
affiliation: zhu_julie@vip.sina.com
name: Lan Zhu
role: PRINCIPAL_INVESTIGATOR
References: