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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Floor

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • Maternal and Child Health Hospital of Anhui province
      • Contact: Hongmei Zhou; Email: 1973517466@qq.com
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Science
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Recruiting
      • Gansu Province Maternal and Child Care Hospital
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • Foshan Maternal and Child Health Care Hospital
      • Contact: Zhengxian Xu
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Huan Ge; Email: huange@njmu.edu.cn
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • Xi'an' Fourth Hospital
      • Contact: Xinwen Zhang
  • Zhejiang
    • Ningbo, Zhejiang, China, 315012
      • Recruiting
      • Ningbo Women & Children's Hospital
      • Contact: Bengui Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
resting amplitude (µV) pre baseline	pretest one minute rest	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Ningbo Women & Children's Hospital; Xi'an Fourth Hospital; Maternal and Child Health Hospital of Anhui Province; Gansu Province Maternal and Child Care Hospital; Foshan Maternity and Child Health Care Hospital
• Investigators: Principal Investigator: Lan Zhu, zhu_julie@vip.sina.com

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: January 26, 2020
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: sEMG-Normal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No