A National Observation Study on Pelvic Floor Dysfunction Diseases in China

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06037226

Enrollment

10000

Registered

2023-09-14

Start date

2023-09-30

Completion date

2024-12-31

Last updated

2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Dysfunction

Keywords

Pelvic floor dysfunction, postpartum women

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.

Interventions

BEHAVIORALPostpartum pelvic floor rehabilitation

biofeedback with Pelvic floor muscle training (PFMT)

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Urinary incontinence	6 months	UI will be diagnosed via gynecological examination and self-reported symptoms

Secondary

Measure	Time frame	Description
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).

Other

Measure	Time frame	Description
Pelvic muscle function	6 months	In palpation, pelvic floor muscle strength will be graded based on the Oxford Muscle Scale and Electronic-muscle strength Medical Record system

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026