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

NCT ID: NCT04245137

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pelvic Floor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Xi'an People's Hospital (Xi'an Fourth Hospital)

OTHER

Sponsor Role collaborator

Maternal and Child Health Hospital of Anhui Province

UNKNOWN

Sponsor Role collaborator

Ningbo Women & Children's Hospital

OTHER

Sponsor Role collaborator

Gansu Province Maternal and Child Care Hospital

UNKNOWN

Sponsor Role collaborator

Foshan Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan Zhu

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Maternal and Child Health Hospital of Anhui Province

Hefei, Anhui, China

Site Status RECRUITING

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status RECRUITING

Gansu Province Maternal and Child Care Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

Foshan Maternal and Child Health Care Hospital

Foshan, Guangdong, China

Site Status RECRUITING

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Xi'an' Fourth Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Ningbo Women & Children's Hospital

Ningbo, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juan Chen

Role: CONTACT

[email protected]
13521354364

Facility Contacts

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Hongmei Zhou

Role: primary

[email protected]

Juan Chen

Role: primary

[email protected]
13521354364

Min Zhou

Role: primary

Zhengxian Xu

Role: primary

Huan Ge

Role: primary

[email protected]

Xinwen Zhang

Role: primary

Bengui Jiang

Role: primary

Other Identifiers

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sEMG-Normal

Identifier Type: -

Identifier Source: org_study_id

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