AzTrials
AzTrials

Pelvic FloorNCT04245137

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

An observational study of Pelvic Floor, run by Peking Union Medical College Hospital at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pelvic Floor
How many people
1,000 participants
Where
7 sitesChina
Study dates
1 Mar 2020to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: healthy females with no symptoms of pelvic floor dysfunciton and normal contraciton strength, and at least 2 yrs postpartum.

Who may be able to join

  • 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;

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

Juan Chen contact

13521354364

pumchcj@sina.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100730

    Juan Chen, 13521354364, pumchcj@sina.com

    Lan Zhu

    Recruiting

  • Foshan Maternal and Child Health Care Hospital

    Foshan, Guangdong, 528000

    Zhengxian Xu

    Recruiting

  • Maternal and Child Health Hospital of Anhui Province

    Hefei, Anhui, 230001

    Hongmei Zhou, 1973517466@qq.com

    Recruiting

  • Gansu Province Maternal and Child Care Hospital

    Lanzhou, Gansu, 730050

    Min Zhou

    Recruiting

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Huan Ge, huange@njmu.edu.cn

    Jie Wu

    Recruiting

  • Ningbo Women & Children's Hospital

    Ningbo, Zhejiang, 315012

    Bengui Jiang

    Recruiting

  • Xi'an' Fourth Hospital

    Xi’an, Shanxi

    Xinwen Zhang

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Pelvic Floor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. resting amplitude (µV) pre baseline

    pretest one minute rest

    Measured: 1 day

Secondary outcomes (10)

  1. coefficients of variability pre baseline

    standard deviation divided by amplitudes at pretest resting period

    Measured: 1 day

  2. maximum rapid contraction amplitude (µV)

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

    Measured: 1 day

  3. recovery time at termination of rapid contraction(second)

    recovery time until all muscles relax

    Measured: 1 day

  4. average amplitude of tonic contraction(µV)

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

    Measured: 1 day

  5. coefficients of variability for the tonic contraction

    standard deviation divided by amplitudes at tonic contraction period

    Measured: 1 day

  6. recovery time at termination of tonic contraction(second)

    recovery time until all muscles relax

    Measured: 1 day

  7. average amplitude of endurance contraction(µV)

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

    Measured: 1 day

  8. coefficients of variability for the endurance contraction

    standard deviation divided by amplitudes at endurance contraction period

    Measured: 1 day

  9. resting amplitude (µV) post baseline

    after-test one minute rest

    Measured: 1 day

  10. coefficients of variability post baseline

    standard deviation divided by amplitudes at after-test resting period

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04245137
Sponsor's protocol ID
sEMG-Normal
Status last verified
Jan 2020
First submitted
26 Jan 2020
Last updated
28 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Floor, run by Peking Union Medical College Hospital at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Juan Chen (13521354364, pumchcj@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

resting amplitude (µV) pre baseline (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04245137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in