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Not yet recruiting NCT07608146

Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System

Observational Stress Urinary Incontinence (SUI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stress Urinary Incontinence (SUI). Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Differences in Pelvic Floor Movement Levels Based on Population Characteristics and the Construction of an Assessment System

Overview

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.

Primary outcome measures

  • Pelvic floor movement level assessment [Time frame: 2 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 20 centers
  • Anhui Provincial Hospital — Hefei
  • Peking Union Medical College Hospital — Beijing
  • Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture — Linxia
  • The First People's Hospital of Qinzhou — Qinzhou
  • Guizhou Provincial People's Hospital — Guiyang
  • Zunyi Maternal and Child Health Hospital — Zunyi
  • Tangshan Maternal and Child Health Care Hospital — Tangshan
  • Mudanjiang Maternal and Child Health Hospital — Mudanjiang
  • … and 12 more centers

Identifiers

NCT: NCT07608146 · K10476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗