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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Stress Urinary Incontinence (SUI)

Study type: Observational

Funder types: Other

Identifiers

NCT07608146

K10476

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Healthy group

Description:

Females aged between 18 to 60 without any pelvic floor dysfunction symptoms

Stress urinary incontinence group

Description:

Females aged between 18 to 60 years with only stress urinary incontinence symptoms