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Clinical Trials/NCT04245137
NCT04245137
Unknown
Not Applicable

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

Peking Union Medical College Hospital7 sites in 1 country1,000 target enrollmentMarch 1, 2020
ConditionsPelvic Floor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor
Sponsor
Peking Union Medical College Hospital
Enrollment
1000
Locations
7
Primary Endpoint
resting amplitude (µV) pre baseline
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

resting amplitude (µV) pre baseline

Time Frame: 1 day

pretest one minute rest

Secondary Outcomes

  • recovery time at termination of rapid contraction(second)(1 day)
  • coefficients of variability for the tonic contraction(1 day)
  • average amplitude of tonic contraction(µV)(1 day)
  • coefficients of variability pre baseline(1 day)
  • maximum rapid contraction amplitude (µV)(1 day)
  • recovery time at termination of tonic contraction(second)(1 day)
  • coefficients of variability post baseline(1 day)
  • average amplitude of endurance contraction(µV)(1 day)
  • coefficients of variability for the endurance contraction(1 day)
  • resting amplitude (µV) post baseline(1 day)

Study Sites (7)

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