Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System
1 other identifier
observational
2,000
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedStudy Start
First participant enrolled
May 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 27, 2026
May 1, 2026
5 months
May 8, 2026
May 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pelvic floor movement level assessment
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
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Anhui Provincial Hospital
Hefei, Anhui, 23001, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture
Linxia, Gansu, 731100, China
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, 535000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Zunyi Maternal and Child Health Hospital
Zunyi, Guizhou, 563000, China
Tangshan Maternal and Child Health Care Hospital
Tangshan, Hebei, 063000, China
Mudanjiang Maternal and Child Health Hospital
Mudanjiang, Heilongjiang, 157000, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277102, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Shanxi Maternal and Child Health Hospital
Taiyuan, Shanxi, 030013, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yan'an Hospital Affiliated to Kunming Medical University
Kunming, Yunnan, 650032, China
Ningbo Ninth Hospital
Ningbo, Zhejiang, 315020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lan Zhu, Doctor
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Chair
Study Record Dates
First Submitted
May 8, 2026
First Posted
May 27, 2026
Study Start
May 30, 2026
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share