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

N/ANot Yet RecruitingNCT07608146

Peking Union Medical College Hospital2,000 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Stress Urinary Incontinence (SUI)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (20)

Anhui Provincial Hospital

Hefei, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture

Linxia, Gansu, China

The First People's Hospital of Qinzhou

Qinzhou, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Zunyi Maternal and Child Health Hospital

Zunyi, Guizhou, China

Tangshan Maternal and Child Health Care Hospital

Tangshan, Hebei, China

Mudanjiang Maternal and Child Health Hospital

Mudanjiang, Heilongjiang, China

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

...and 10 more locations

Outcomes

Primary Outcomes

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.

Time frame: 2 minutes