Pelvic Floor DysfunctionNCT06037226
A National Observation Study on Pelvic Floor Dysfunction Diseases in China
An observational study of Pelvic Floor Dysfunction, run by Peking Union Medical College Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Dysfunction
- What is being tested?
- Postpartum pelvic floor rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All adult women in early postnatal period, 42 days+15 days after delivery, are eligible to participate.
Who may be able to join
- Postpartum women: 42 days+15 days after delivery
- Age:20-45
- Consent to participate in the research.
Who cannot join
- 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
About this study
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
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
- Being tested
- Postpartum pelvic floor rehabilitation
- Keywords
- Pelvic floor dysfunction, postpartum women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum pelvic floor rehabilitationBehavioural
biofeedback with Pelvic floor muscle training (PFMT)
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary incontinence
UI will be diagnosed via gynecological examination and self-reported symptoms
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfunctionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037226
- Sponsor's protocol ID
- PekingUMCH-2021YFC20701303
- Status last verified
- Oct 2022
- First submitted
- 8 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06037226
- Acronym / sponsor ID
- PekingUMCH-2021YFC20701303
- Conditions
- Pelvic Floor Dysfunction
- Keywords
- Pelvic floor dysfunction, postpartum women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All adult women in early postnatal period, 42 days+15 days after delivery, are eligible to participate.
Key inclusion criteria (3 listed)
- Postpartum women: 42 days+15 days after delivery
- Age:20-45
- Consent to participate in the research.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum pelvic floor rehabilitationbiofeedback with Pelvic floor muscle training (PFMT) | Behavioural | – |
Primary outcome
Urinary incontinence
Time frame: 6 months
UI will be diagnosed via gynecological examination and self-reported symptoms
1 secondary outcome
Pelvic organ prolapse
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Pelvic Floor Dysfunction
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction at Postpartum Woman
Postpartum Pelvic Floor Function and Symptoms
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Recruiting
HOme PElvic Floor Improvement Trainer Trial
Pelvic Pain, Pelvic Floor Dysfunction
Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Dysfunction, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary incontinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.