- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608146
Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System
24. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tangdi Lin, Doctor
- Telefonnummer: +86-13547909619
- E-mail: tangdilin1997@sina.com
Undersøgelse Kontakt Backup
- Navn: Juan Chen, Doctor
- Telefonnummer: +86-13521354364
- E-mail: chenjuan06084@pumch.cn
Studiesteder
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Anhui
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Hefei, Anhui, Kina, 23001
- Anhui Provincial Hospital
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Kontakt:
- Cheng Peng
- Telefonnummer: +86-18010882012
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Peking Union Medical College Hospital
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Kontakt:
- Tangdi Lin, Doctor
- Telefonnummer: +86-13547909619
- E-mail: tangdilin1997@sina.com
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Kontakt:
- Juan Chen, Doctor
- Telefonnummer: +86-13521354364
- E-mail: chenjuan06804@pumch.cn
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Ledende efterforsker:
- Lan Zhu, Doctor
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Gansu
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Linxia, Gansu, Kina, 731100
- Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture
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Kontakt:
- Ruimin Ma
- Telefonnummer: +86-13909307361
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Guangxi
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Qinzhou, Guangxi, Kina, 535000
- The First People's Hospital of Qinzhou
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Kontakt:
- Jie Liang
- Telefonnummer: +86-18607779337
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Guizhou
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Guiyang, Guizhou, Kina, 550002
- Guizhou Provincial People's Hospital
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Kontakt:
- Dan Zi
- Telefonnummer: +86-13908519916
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Zunyi, Guizhou, Kina, 563000
- Zunyi Maternal and Child Health Hospital
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Kontakt:
- Jing Zhao
- Telefonnummer: +86-18108535556
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Hebei
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Tangshan, Hebei, Kina, 063000
- Tangshan Maternal and Child Health Care Hospital
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Kontakt:
- Xuemei Wang
- Telefonnummer: +86-15031524897
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Heilongjiang
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Mudanjiang, Heilongjiang, Kina, 157000
- Mudanjiang Maternal and Child Health Hospital
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Kontakt:
- Xiulian Lu
- Telefonnummer: +86-13946349175
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Henan
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Zhengzhou, Henan, Kina, 450000
- The Second Affiliated Hospital of Zhengzhou University
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Kontakt:
- Hu Zhao
- Telefonnummer: +86-15837168696
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Zhengzhou, Henan, Kina, 450000
- People's Hospital of Zhengzhou
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Kontakt:
- Hongjuan Li
- Telefonnummer: +86-15238022969
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
- the First Affiliated Hospital of Nanjing Medical University
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Kontakt:
- Ziyan Jiang
- Telefonnummer: +86-13512534017
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Shandong
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Zaozhuang, Shandong, Kina, 277102
- Zaozhuang Municipal Hospital
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Kontakt:
- Jian Wang
- Telefonnummer: +86-13616377899
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200233
- Shanghai Sixth People's Hospital
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Kontakt:
- Qinkai Wu
- Telefonnummer: +86-18930177603
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Shanghai, Shanghai Municipality, Kina, 200072
- Shanghai Tenth People's Hospital
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Kontakt:
- Feng Xing
- Telefonnummer: +86-18917683168
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Shanxi
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Taiyuan, Shanxi, Kina, 030013
- Shanxi Maternal and Child Health Hospital
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Kontakt:
- Pengyan Qiao
- Telefonnummer: +86-13834609309
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Sichuan
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Chengdu, Sichuan, Kina, 611130
- Chengdu Fifth People's Hospital
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Kontakt:
- Xu Yang
- Telefonnummer: +86-18229488642
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300211
- The Second Hospital of Tianjin Medical University
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Kontakt:
- Cuiping Le
- Telefonnummer: +86-18822657722
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Xinjiang
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Ürümqi, Xinjiang, Kina, 830054
- The First Affiliated Hospital of Xinjiang Medical University
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Kontakt:
- Junqi Ma
- Telefonnummer: +86-13325600001
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Yunnan
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Kunming, Yunnan, Kina, 650032
- Yan'an Hospital Affiliated to Kunming Medical University
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Zhejiang
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Ningbo, Zhejiang, Kina, 315020
- Ningbo Ninth Hospital
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Kontakt:
- Yingying Gao
- Telefonnummer: +86-13616566863
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pelvic floor movement level assessment
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lan Zhu, Doctor, Peking Union Medical College Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. maj 2026
Primær færdiggørelse (Anslået)
31. oktober 2026
Studieafslutning (Anslået)
31. august 2027
Datoer for studieregistrering
Først indsendt
8. maj 2026
Først indsendt, der opfyldte QC-kriterier
24. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Vandladningsforstyrrelser
- Nedre urinvejssymptomer
- Urologiske manifestationer
- Ufrivillig vandladning
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Urininkontinens, stress
Andre undersøgelses-id-numre
- K10476
Plan for individuelle deltagerdata (IPD)
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