A National Observation Study on Pelvic Floor Dysfunction Diseases in China

NCT ID: NCT06037226

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Pelvic Floor Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Postpartum pelvic floor rehabilitation

biofeedback with Pelvic floor muscle training (PFMT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PekingUMCH-2021YFC20701303

Identifier Type: -

Identifier Source: org_study_id

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