A National Observation Study on Pelvic Floor Dysfunction Diseases in China

Not yet recruiting

• Conditions: Pelvic Floor Dysfunction

• Registration Number: NCT06037226
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

In this protocol, our team intend to conduct a nation-wide multicenter cohort research to screening for PFD symptoms in early postnatal women in China. Beside clinically significant symptoms, we will also measure the recovery trend of pelvic muscle function, aiming to determine the clinically significant alterations that are sensitive to predict the PFD risks. This is an observational prospective cohort study, following a natural regular clinical visit process. Patients will voluntarily decide whether to receive PFD related treatments and the types of treatments to adopt. Therefore, we will also be able to compare the effectiveness of treatments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Primary Completion: 2024-02
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

1. Postpartum women: 42 days+15 days after delivery
2. Age:20-45
3. Consent to participate in the research.

Exclusion Criteria

1. Refuse gynecological and/or obstetrical examinations.
2. Diagnosed with psychiatric disorders
3. Diagnosed with other severe illnesses
4. Received pelvic floor treatments
5. Other factors that may confound with the research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary incontinence	6 months	UI will be diagnosed via gynecological examination and self-reported symptoms

Secondary Outcome Measures

Name	Time	Method
Pelvic organ prolapse	6 months	Physical examinations will be performed to diagnose the incidence and degree of organ prolapse (i.e. anterior vaginal wall prolapse, posterior vaginal wall prolapse, uterine prolapse, and vaginal apex prolapse) according to the Pelvic Organ Prolapse Quantification (POP-Q).