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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07608146
Enrollment
2000
Registered
2026-05-27
Start date
2026-05-30
Completion date
2027-08-31
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Stress urinary incontinence, Pelvic floor muscle strength, Non-invasive technology, Pelvic floor dysfunction

Brief summary

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic floor movement level assessment2 minutesThe 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.

Countries

China

Contacts

CONTACTTangdi Lin, Doctor
tangdilin1997@sina.com+86-13547909619
CONTACTJuan Chen, Doctor
chenjuan06084@pumch.cn+86-13521354364
PRINCIPAL_INVESTIGATORLan Zhu, Doctor

Peking Union Medical College Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026