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

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 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

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
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

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

Peking Union Medical College Hospital

Investigators

  • 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)

May 30, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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