About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial 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.
Sponsors and contacts
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