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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04245137
Enrollment
1000
Registered
2020-01-28
Start date
2020-03-01
Completion date
2020-12-31
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Xi'an People's Hospital (Xi'an Fourth Hospital)
CollaboratorOTHER
Maternal and Child Health Hospital of Anhui Province
CollaboratorUNKNOWN
Ningbo Women & Children's Hospital
CollaboratorOTHER
Gansu Province Maternal and Child Care Hospital
CollaboratorUNKNOWN
Foshan Maternity and Child Health Care Hospital
CollaboratorUNKNOWN
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
resting amplitude (µV) pre baseline1 daypretest one minute rest

Secondary

MeasureTime frameDescription
maximum rapid contraction amplitude (µV)1 dayfive rapid contractions (Flicks) with a 10 second rest before each one (phasic).
recovery time at termination of rapid contraction(second)1 dayrecovery time until all muscles relax
average amplitude of tonic contraction(µV)1 dayfive 10 second contractions with a 10 second rest before each one (tonic)
coefficients of variability for the tonic contraction1 daystandard deviation divided by amplitudes at tonic contraction period
coefficients of variability pre baseline1 daystandard deviation divided by amplitudes at pretest resting period
average amplitude of endurance contraction(µV)1 dayA 10 second rest followed by a single endurance contraction of 60 seconds (endurance)
coefficients of variability for the endurance contraction1 daystandard deviation divided by amplitudes at endurance contraction period
resting amplitude (µV) post baseline1 dayafter-test one minute rest
coefficients of variability post baseline1 daystandard deviation divided by amplitudes at after-test resting period
recovery time at termination of tonic contraction(second)1 dayrecovery time until all muscles relax

Countries

China

Contacts

Primary ContactJuan Chen
pumchcj@sina.com13521354364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026