Reference Intervals of the sEMG of the Pelvic Floor in Healthy Female

Pelvic Floor Clinical Trial

Official title:

A Cross-sectional Study of Female Pelvic Floor Surface Electromyography in Chinese Healthy Female

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245137
• Other study ID #: sEMG-Normal
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: Peking Union Medical College Hospital
• Contact: Juan Chen
• Phone: 13521354364
• Email: pumchcj[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• 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 and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Science	Beijing	Beijing
China	Foshan Maternal and Child Health Care Hospital	Foshan	Guangdong
China	Maternal and Child Health Hospital of Anhui Province	Hefei	Anhui
China	Gansu Province Maternal and Child Care Hospital	Lanzhou	Gansu
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Ningbo Women & Children's Hospital	Ningbo	Zhejiang
China	Xi'an' Fourth Hospital	Xi'an	Shanxi

Sponsors (7)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Foshan Maternity and Child Health Care Hospital, Gansu Province Maternal and Child Care Hospital, Maternal and Child Health Hospital of Anhui Province, Ningbo Women and Children's Hospital, The First Affiliated Hospital with Nanjing Medical University, Xi'an Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resting amplitude (µV) pre baseline	pretest one minute rest	1 day
Secondary	coefficients of variability pre baseline	standard deviation divided by amplitudes at pretest resting period	1 day
Secondary	maximum rapid contraction amplitude (µV)	five rapid contractions (Flicks) with a 10 second rest before each one (phasic).	1 day
Secondary	recovery time at termination of rapid contraction(second)	recovery time until all muscles relax	1 day
Secondary	average amplitude of tonic contraction(µV)	five 10 second contractions with a 10 second rest before each one (tonic)	1 day
Secondary	coefficients of variability for the tonic contraction	standard deviation divided by amplitudes at tonic contraction period	1 day
Secondary	recovery time at termination of tonic contraction(second)	recovery time until all muscles relax	1 day
Secondary	average amplitude of endurance contraction(µV)	A 10 second rest followed by a single endurance contraction of 60 seconds (endurance)	1 day
Secondary	coefficients of variability for the endurance contraction	standard deviation divided by amplitudes at endurance contraction period	1 day
Secondary	resting amplitude (µV) post baseline	after-test one minute rest	1 day
Secondary	coefficients of variability post baseline	standard deviation divided by amplitudes at after-test resting period	1 day