A National Observation Study on Pelvic Floor Dysfunction Diseases in China

NCT06037226 | Unknown DMC

• 1 other identifier: PekingUMCH-2021YFC20701303
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Floor Dysfunction

Keywords

Pelvic floor dysfunction, postpartum women

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence

  UI will be diagnosed via gynecological examination and self-reported symptoms

  6 months

Secondary Outcomes (1)

• Pelvic organ prolapse

  6 months

Other Outcomes (1)

• Pelvic muscle function

  6 months

Interventions

Postpartum pelvic floor rehabilitation BEHAVIORAL

biofeedback with Pelvic floor muscle training (PFMT)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All adult women in early postnatal period, 42 days+15 days after delivery, are eligible to participate.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 14, 2023
• Study Start: September 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share