Differences in Pelvic Floor Movement Levels Based on Population Characteristics and the Construction of an Assessment System
| Registry | NCT07608146 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 2000 (Estimated) |
| Sponsor | Peking Union Medical College Hospital (Other) |
| Conditions | Stress Urinary Incontinence (SUI) |
| Dates | start 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 |
| Locations | 20 sites in China |
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All trials for Stress Urinary Incontinence (SUI)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy group | Females aged between 18 to 60 without any pelvic floor dysfunction symptoms | ||
| Stress urinary incontinence group | Females aged between 18 to 60 years with only stress urinary incontinence symptoms |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Anhui Provincial Hospital | Hefei, Anhui | China | |
| Peking Union Medical College Hospital | Beijing, Beijing Municipality | China | |
| Maternal and Child Health Hospital of Linxia Hui Autonomous Prefecture | Linxia, Gansu | China | |
| The First People's Hospital of Qinzhou | Qinzhou, Guangxi | China | |
| Guizhou Provincial People's Hospital | Guiyang, Guizhou | China | |
| Zunyi Maternal and Child Health Hospital | Zunyi, Guizhou | China | |
| Tangshan Maternal and Child Health Care Hospital | Tangshan, Hebei | China | |
| Mudanjiang Maternal and Child Health Hospital | Mudanjiang, Heilongjiang | China | |
| People's Hospital of Zhengzhou | Zhengzhou, Henan | China | |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan | China | |
| the First Affiliated Hospital of Nanjing Medical University | Nanjing, Jiangsu | China | |
| Zaozhuang Municipal Hospital | Zaozhuang, Shandong | China | |
| Shanghai Tenth People's Hospital | Shanghai, Shanghai Municipality | China | |
| Shanghai Sixth People's Hospital | Shanghai, Shanghai Municipality | China | |
| Shanxi Maternal and Child Health Hospital | Taiyuan, Shanxi | China | |
| Chengdu Fifth People's Hospital | Chengdu, Sichuan | China | |
| The Second Hospital of Tianjin Medical University | Tianjin, Tianjin Municipality | China | |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi, Xinjiang | China | |
| Yan'an Hospital Affiliated to Kunming Medical University | Kunming, Yunnan | China | |
| Ningbo Ninth Hospital | Ningbo, Zhejiang | China |