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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04245137
Collaborator
The First Affiliated Hospital with Nanjing Medical University (Other), Xi'an Fourth Hospital (Other), Maternal and Child Health Hospital of Anhui Province (Other), Ningbo Women & Children's Hospital (Other), Gansu Province Maternal and Child Care Hospital (Other), Foshan Maternity and Child Health Care Hospital (Other)
1,000
7
10
142.9
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Cross-sectional Study of Female Pelvic Floor Surface Electromyography in Chinese Healthy Female
    Anticipated Study Start Date :
    Mar 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. resting amplitude (µV) pre baseline [1 day]

      pretest one minute rest

    Secondary Outcome Measures

    1. coefficients of variability pre baseline [1 day]

      standard deviation divided by amplitudes at pretest resting period

    2. maximum rapid contraction amplitude (µV) [1 day]

      five rapid contractions (Flicks) with a 10 second rest before each one (phasic).

    3. recovery time at termination of rapid contraction(second) [1 day]

      recovery time until all muscles relax

    4. average amplitude of tonic contraction(µV) [1 day]

      five 10 second contractions with a 10 second rest before each one (tonic)

    5. coefficients of variability for the tonic contraction [1 day]

      standard deviation divided by amplitudes at tonic contraction period

    6. recovery time at termination of tonic contraction(second) [1 day]

      recovery time until all muscles relax

    7. average amplitude of endurance contraction(µV) [1 day]

      A 10 second rest followed by a single endurance contraction of 60 seconds (endurance)

    8. coefficients of variability for the endurance contraction [1 day]

      standard deviation divided by amplitudes at endurance contraction period

    9. resting amplitude (µV) post baseline [1 day]

      after-test one minute rest

    10. coefficients of variability post baseline [1 day]

      standard deviation divided by amplitudes at after-test resting period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. 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;
    1. No birth or 2 years after the last delivery;
    Exclusion Criteria:
      1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maternal and Child Health Hospital of Anhui Province Hefei Anhui China 230001
    2 Peking Union Medical College Hospital, Chinese Academy of Medical Science Beijing Beijing China 100730
    3 Gansu Province Maternal and Child Care Hospital Lanzhou Gansu China 730050
    4 Foshan Maternal and Child Health Care Hospital Foshan Guangdong China 528000
    5 the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210029
    6 Xi'an' Fourth Hospital Xi'an Shanxi China
    7 Ningbo Women & Children's Hospital Ningbo Zhejiang China 315012

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • The First Affiliated Hospital with Nanjing Medical University
    • Xi'an Fourth Hospital
    • Maternal and Child Health Hospital of Anhui Province
    • Ningbo Women & Children's Hospital
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04245137
    Other Study ID Numbers:
    • sEMG-Normal
    First Posted:
    Jan 28, 2020
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 28, 2020