Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System

May 24, 2026 updated by: Lan Zhu, Peking Union Medical College Hospital

Differences in Pelvic Floor Movement Levels Based on Population Characteristics and the Construction of an Assessment System

The purpose of this study is to integrate millimeter-wave radar technology to investigate the dynamic movement characteristics of the pelvic floor muscles in patients with different Body Mass Index (BMI) and stress urinary incontinence. Based on this, a large database of pelvic floor movement parameters for Chinese women will be constructed, and a multi-subgroup standard atlas of pelvic floor muscle movement will be established to promote the standardized application of this technology in obstetrics and gynecology clinical assessments. This study also aims to explore the clinical value of pelvic floor movement assessment within the pelvic floor evaluation system, providing directions and insights for establishing a systematic evaluation system and standardizing the diagnosis and treatment of pelvic floor disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 23001
        • Anhui Provincial Hospital
        • Contact:
          • Cheng Peng
          • Phone Number: +86-18010882012
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lan Zhu, Doctor
    • Gansu
      • Linxia, Gansu, China, 731100
        • Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture
        • Contact:
          • Ruimin Ma
          • Phone Number: +86-13909307361
    • Guangxi
      • Qinzhou, Guangxi, China, 535000
        • The First People's Hospital of Qinzhou
        • Contact:
          • Jie Liang
          • Phone Number: +86-18607779337
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
        • Contact:
          • Dan Zi
          • Phone Number: +86-13908519916
      • Zunyi, Guizhou, China, 563000
        • Zunyi Maternal and Child Health Hospital
        • Contact:
          • Jing Zhao
          • Phone Number: +86-18108535556
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Tangshan Maternal and Child Health Care Hospital
        • Contact:
          • Xuemei Wang
          • Phone Number: +86-15031524897
    • Heilongjiang
      • Mudanjiang, Heilongjiang, China, 157000
        • Mudanjiang Maternal and Child Health Hospital
        • Contact:
          • Xiulian Lu
          • Phone Number: +86-13946349175
    • Henan
      • Zhengzhou, Henan, China, 450000
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
          • Hu Zhao
          • Phone Number: +86-15837168696
      • Zhengzhou, Henan, China, 450000
        • People's Hospital of Zhengzhou
        • Contact:
          • Hongjuan Li
          • Phone Number: +86-15238022969
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
          • Ziyan Jiang
          • Phone Number: +86-13512534017
    • Shandong
      • Zaozhuang, Shandong, China, 277102
        • Zaozhuang Municipal Hospital
        • Contact:
          • Jian Wang
          • Phone Number: +86-13616377899
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Shanghai Sixth People's Hospital
        • Contact:
          • Qinkai Wu
          • Phone Number: +86-18930177603
      • Shanghai, Shanghai Municipality, China, 200072
        • Shanghai Tenth People's Hospital
        • Contact:
          • Feng Xing
          • Phone Number: +86-18917683168
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Maternal and Child Health Hospital
        • Contact:
          • Pengyan Qiao
          • Phone Number: +86-13834609309
    • Sichuan
      • Chengdu, Sichuan, China, 611130
        • Chengdu Fifth People's Hospital
        • Contact:
          • Xu Yang
          • Phone Number: +86-18229488642
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300211
        • The Second Hospital of Tianjin Medical University
        • Contact:
          • Cuiping Le
          • Phone Number: +86-18822657722
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Junqi Ma
          • Phone Number: +86-13325600001
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Yan'an Hospital Affiliated to Kunming Medical University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315020
        • Ningbo Ninth Hospital
        • Contact:
          • Yingying Gao
          • Phone Number: +86-13616566863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Based on BMI values, it is planned to recruit 200 participants with BMI < 18.5 kg/m², 600 participants with BMI between 18.5 and 24 kg/m², and 200 participants with BMI > 24 kg/m². A total of 1,000 study subjects will be recruited for healhty group and 1,000 for SUI group, amounting to 2,000 participants in total.

Description

Inclusion Criteria:

  • Female, aged between 18 and 60 years old
  • Signed the informed consent form
  • Healthy group demonstrated no pelvic floor dysfunction
  • SUI group had stress urinary incontinence symptom

Exclusion Criteria:

  • Participants with cognitive behavioral disorders, mental illnesses, or those who are unable to cooperate
  • Participants who cannot demonstrate correct pelvic floor muscle contraction
  • Participants who were within 1 year postpartum
  • Participants who were post hysterectomy
  • Participants who had pain during internal exam or refused to have internal exam
  • SUI group who had pelvic organ prolapse symptoms or whose POP-Q lowest level reached or exceeded the hymenal ring
  • SUI group had urgency urinary incontinence symptoms
  • SUI group had chronic constipation symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy group
Females aged between 18 to 60 without any pelvic floor dysfunction symptoms
Stress urinary incontinence group
Females aged between 18 to 60 years with only stress urinary incontinence symptoms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pelvic floor movement level assessment
Time Frame: 2 minutes
The outcome measure is the pelvic floor movement level assessed on the magnetic stimulator. The patient is asked to perform pelvic floor muscle contraction and relaxation according to voice prompts, and the assessment data is recorded. The outcome includes maximum/mean values, rise time, and recovery time. The reference maximum or mean value is ≥2.0 and ≥1.5 millimeters. The reference rise and recovery time is <0.5 second and <0.7 second.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lan Zhu, Doctor, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K10476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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