Stress Urinary Incontinence (SUI)NCT07608146
Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System
An observational study of Stress Urinary Incontinence (SUI), run by Peking Union Medical College Hospital at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- How many people
- 2,000 participants
- Where
- 20 sitesChina
- Study dates
- 30 May 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Tangdi Lin, Doctor, +86-13547909619, tangdilin1997@sina.com
Juan Chen, Doctor, +86-13521354364, chenjuan06804@pumch.cn
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Xu Yang, +86-18229488642
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Dan Zi, +86-13908519916
Anhui Provincial Hospital
Hefei, Anhui, 23001
Cheng Peng, +86-18010882012
Yan'an Hospital Affiliated to Kunming Medical University
Kunming, Yunnan, 650032
Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture
Linxia, Gansu, 731100
Ruimin Ma, +86-13909307361
Mudanjiang Maternal and Child Health Hospital
Mudanjiang, Heilongjiang, 157000
Xiulian Lu, +86-13946349175
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Ziyan Jiang, +86-13512534017
Ningbo Ninth Hospital
Ningbo, Zhejiang, 315020
Yingying Gao, +86-13616566863
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, 535000
Jie Liang, +86-18607779337
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Feng Xing, +86-18917683168
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Qinkai Wu, +86-18930177603
Shanxi Maternal and Child Health Hospital
Taiyuan, Shanxi, 030013
Pengyan Qiao, +86-13834609309
Tangshan Maternal and Child Health Care Hospital
Tangshan, Hebei, 063000
Xuemei Wang, +86-15031524897
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Cuiping Le, +86-18822657722
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Junqi Ma, +86-13325600001
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277102
Jian Wang, +86-13616377899
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000
Hongjuan Li, +86-15238022969
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Hu Zhao, +86-15837168696
Zunyi Maternal and Child Health Hospital
Zunyi, Guizhou, 563000
Jing Zhao, +86-18108535556
About this study
Official title: 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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Stress urinary incontinence, Pelvic floor muscle strength, Non-invasive technology, Pelvic floor dysfunction
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start30 May 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Zhu, Peking Union Medical College Hospital
- Investigators
- Lan Zhu, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608146
- Sponsor's protocol ID
- K10476
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Pelvic Floor Movement Levels Based on Population Characteristics and the Construction of an Assessment System
- ClinicalTrials.gov ID
- NCT07608146
- Acronym / sponsor ID
- K10476
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Stress urinary incontinence, Pelvic floor muscle strength, Non-invasive technology, Pelvic floor dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lan Zhu, Doctor principal investigator
Peking Union Medical College Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence (SUI), run by Peking Union Medical College Hospital at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tangdi Lin, Doctor (+86-13547909619, tangdilin1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor movement level assessment (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.