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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorPeking Union Medical College Hospital

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 2 trial groups
Group A: Healthy group
Group B: Stress urinary incontinence group

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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