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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

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

Undersøgelse Kontakt Backup

Studiesteder

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

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

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