A National Observation Study on Pelvic Floor Dysfunction Diseases in China

Pelvic Floor Dysfunction Clinical Trial

Official title:

A National Observation Study on Pelvic Floor Dysfunction Diseases Based on Electrophysiological Technology and a Newly Established Prevention and Treatment System in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06037226
• Other study ID #: PekingUMCH-2021YFC20701303
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Dysfunction

Intervention

Behavioral:
• Postpartum pelvic floor rehabilitation
biofeedback with Pelvic floor muscle training (PFMT)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pelvic muscle function	In palpation, pelvic floor muscle strength will be graded based on the Oxford Muscle Scale and Electronic-muscle strength Medical Record system	6 months
Primary	Urinary incontinence	UI will be diagnosed via gynecological examination and self-reported symptoms	6 months
Secondary	Pelvic organ prolapse	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).	6 months