NCT04245137

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 26, 2020

Last Update Submit

January 26, 2020

Conditions

Pelvic Floor

Outcome Measures

Primary Outcomes (1)

  • resting amplitude (µV) pre baseline

    pretest one minute rest

    1 day

Secondary Outcomes (10)

  • coefficients of variability pre baseline

    1 day

  • maximum rapid contraction amplitude (µV)

    1 day

  • recovery time at termination of rapid contraction(second)

    1 day

  • average amplitude of tonic contraction(µV)

    1 day

  • coefficients of variability for the tonic contraction

    1 day

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Maternal and Child Health Hospital of Anhui Province

Hefei, Anhui, 230001, China

RECRUITING

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100730, China

RECRUITING

Gansu Province Maternal and Child Care Hospital

Lanzhou, Gansu, 730050, China

RECRUITING

Foshan Maternal and Child Health Care Hospital

Foshan, Guangdong, 528000, China

RECRUITING

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Xi'an' Fourth Hospital

Xi’an, Shanxi, China

RECRUITING

Ningbo Women & Children's Hospital

Ningbo, Zhejiang, 315012, China

RECRUITING

Study Officials

  • Lan Zhu

    zhu_julie@vip.sina.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Chen

CONTACT

13521354364pumchcj@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2020

First Posted

January 28, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)