CClinicalTrials.gg
Status unknownNCT06037226Updated Sep 14, 2023

A National Observation Study on Pelvic Floor Dysfunction Diseases in China

An observational study in Pelvic Floor Dysfunction, sponsored by Peking Union Medical College Hospital. Status unknown. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
10,000
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pelvic Floor Dysfunction

Keywords

  • Pelvic floor dysfunction, postpartum women
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In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
10,000 participants (estimated)
Patient registry
No

Interventions

  • BehavioralPostpartum pelvic floor rehabilitation

    biofeedback with Pelvic floor muscle training (PFMT)

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What researchers measure

Primary outcomes

  1. Urinary incontinence

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

    Time frame: 6 months

Secondary outcomes

  1. 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).

    Time frame: 6 months

Other outcomes

  1. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06037226
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Sep 2023 (estimated)
Primary completion
Feb 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Sep 14, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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