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

NCT07608146 — Not yet recruiting, 2000 participants, Peking Union Medical College Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT07608146
StatusNot yet recruiting
Study typeObservational
Enrollment2000 (Estimated)
SponsorPeking Union Medical College Hospital (Other)
ConditionsStress Urinary Incontinence (SUI)
Datesstart 2026-05-30 (estimated), primary completion 2026-10-31 (estimated), completion 2027-08-31 (estimated), first posted 2026-05-27, last updated 2026-05-27
Locations20 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Stress Urinary Incontinence (SUI)

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Healthy groupFemales aged between 18 to 60 without any pelvic floor dysfunction symptoms
Stress urinary incontinence groupFemales aged between 18 to 60 years with only stress urinary incontinence symptoms

+Outcome measures

Primary outcomes

  • Pelvic floor movement level assessment [2 minutes]: 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.

+Eligibility

Sex: Female, ages: 18 Years to 60 Years, 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

+Locations (20)

FacilityCityCountryStatus
Anhui Provincial HospitalHefei, AnhuiChina
Peking Union Medical College HospitalBeijing, Beijing MunicipalityChina
Maternal and Child Health Hospital of Linxia Hui Autonomous PrefectureLinxia, GansuChina
The First People's Hospital of QinzhouQinzhou, GuangxiChina
Guizhou Provincial People's HospitalGuiyang, GuizhouChina
Zunyi Maternal and Child Health HospitalZunyi, GuizhouChina
Tangshan Maternal and Child Health Care HospitalTangshan, HebeiChina
Mudanjiang Maternal and Child Health HospitalMudanjiang, HeilongjiangChina
People's Hospital of ZhengzhouZhengzhou, HenanChina
The Second Affiliated Hospital of Zhengzhou UniversityZhengzhou, HenanChina
the First Affiliated Hospital of Nanjing Medical UniversityNanjing, JiangsuChina
Zaozhuang Municipal HospitalZaozhuang, ShandongChina
Shanghai Tenth People's HospitalShanghai, Shanghai MunicipalityChina
Shanghai Sixth People's HospitalShanghai, Shanghai MunicipalityChina
Shanxi Maternal and Child Health HospitalTaiyuan, ShanxiChina
Chengdu Fifth People's HospitalChengdu, SichuanChina
The Second Hospital of Tianjin Medical UniversityTianjin, Tianjin MunicipalityChina
The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, XinjiangChina
Yan'an Hospital Affiliated to Kunming Medical UniversityKunming, YunnanChina
Ningbo Ninth HospitalNingbo, ZhejiangChina

+Investigators

  • Lan Zhu, Doctor, Principal investigator, Peking Union Medical College Hospital