NCT03516266

Brief Summary

This study aims to investigate the status of pelvic floor function of healthy female in China, including premenopausal nullipara, premenopausal women with childbirth and postmenopausal 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
7,920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

April 13, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
2.6 years 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

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

April 13, 2018

Last Update Submit

May 10, 2018

Conditions

Pelvic Floor

Keywords

Pelvic floor muscle strengthPremenopausal nulliparaChildbirthPostmenopausal

Outcome Measures

Primary Outcomes (1)

  • maximum vaginal contraction pressure

    it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.

    1 day

Secondary Outcomes (6)

  • Pelvic floor muscle strength

    1 day

  • Pelvic floor muscle strength（repetition）

    1 day

  • Pelvic floor muscle contraction endurance

    1 day

  • pelvic organ prolapse quantification

    1 day

  • the knack test

    1 day

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteers are divided into three groups, and each clinical center requires at least 120 persons in each group. Group A: Premenopausal women without history of abortion or delivery. Group B: Premenopausal women with childbirth (including cesarean section or natural birth). Group C:Postmenopausal women (except surgical menopause).

You may qualify if:

  • Group A：Premenopausal women without history of abortion or delivery
  • Having sex life and tolerable to vaginal examination
  • Premenopausal women without history of abortion over 16 weeks
  • Premenopausal women without history of childbirth
  • Planning to live locally for a long time
  • Group B：Premenopausal women with childbirth
  • Having sex life and tolerable to vaginal examination
  • Premenopausal women with childbirth (including cesarean section or natural birth).
  • Planning to live locally for a long time
  • Group C:Postmenopausal women (over a year, except surgical menopause)
  • Having sex life and tolerable to vaginal examination
  • Postmenopausal women
  • Planning to live locally for a long time

You may not qualify if:

  • Incontinence 4 weeks before enrollment
  • History of fecal incontinence
  • Prolapse beyond the level of the hymen
  • History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
  • History of pelvic radiotherapy
  • History of pelvic floor surgery
  • History of abortion over 16 weeks' pregnancy or in 1 year after delivery
  • Duration of pregnancy
  • Duration of lactation
  • History of hysterectomy
  • Latex allergy
  • Colpitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beiing, 100730, China

RECRUITING

Study Officials

  • Lan Zhu, MD

    Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijing Sun, MD

CONTACT

13651314354sunzhj2001@sina.com

Lan Zhu, MD

CONTACT

zhu_julie@vip.sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 4, 2018

Study Start

May 10, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 11, 2018

Record last verified: 2018-04

Locations

CN(1)