Weight LossWLPFDNCT05987085
Medical Weight Loss on Pelvic Floor Dysfunction
An observational study of Weight Loss and Pelvic Floor Disorders, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effect of medical weight loss on the symptom of pelvic floor dysfunction in obese and overweight women. The main question it aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions in obese or overweight women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Pelvic Floor Disorders
- What is being tested?
- Diet and exercise
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women seeking medical weight loss
Who may be able to join
- Age 18 or higher
- BMI 24 kg/m2 or higher
- Willing to follow the weight loss plan set by the physician follow-up and complete this study
Who cannot join
- Urinary tract infection or gynecologic reproductive system infection in the past month
- Treatment history of pelvic floor disorders
- Pregnancy or delivery in the past half year
- Women with severe systemic disease
- No follow-up conditions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhijing Sun, 19800312327, sunzhj2001@sina.com
Zhao Tian
About this study
Official title: Effect of Medical Weight Loss on Pelvic Floor Dysfunction: a Prospective Observational Study
The goal of this observational study is to learn about the effect of medical weight loss on the symptom of pelvic floor dysfunction in obese and overweight women. The main question it aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions in obese or overweight women.
- Conditions
- Weight Loss, Pelvic Floor Disorders
- Being tested
- Diet and exercise
- Medical subject headings
- Weight Loss, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exerciseOther
Routine intervention included diet control and exercise
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor symptoms before and after medical weight loss
Measured: At least half a year
Secondary outcomes (2)
To explore the related factors of symptom improvement in pelvic floor dysfunction
Measured: At least half a year
To explore the improvement of quality of life before and after medical weight loss
Measured: At least half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Aug 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijing Sun, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987085
- Sponsor's protocol ID
- WLPFD-PUMCH
- Acronym
- WLPFD
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian Z, Chen W, Sun Z. Protocol for a prospective longitudinal cohort study on the effects of non-surgical weight loss on pelvic floor dysfunction. BMJ Open. 2024 Feb 5;14(2):e079143. doi: 10.1136/bmjopen-2023-079143.
PubMed 38316600
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medical Weight Loss on Pelvic Floor Dysfunction: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05987085
- Acronym / sponsor ID
- WLPFD / WLPFD-PUMCH
- Conditions
- Weight Loss, Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Aug 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.
The goal of this observational study is to learn about the effect of medical weight loss on the symptom of pelvic floor dysfunction in obese and overweight women. The main question it aims to answer is: whether medical weight loss improves symptoms of pelvic floor dysfunctions in obese or overweight women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women seeking medical weight loss
Key inclusion criteria (3 listed)
- Age 18 or higher
- BMI 24 kg/m2 or higher
- Willing to follow the weight loss plan set by the physician follow-up and complete this study
Key exclusion criteria (5 listed)
- Urinary tract infection or gynecologic reproductive system infection in the past month
- Treatment history of pelvic floor disorders
- Pregnancy or delivery in the past half year
- Women with severe systemic disease
- No follow-up conditions
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 |
|---|---|---|
| Diet and exerciseRoutine intervention included diet control and exercise | Other | – |
Primary outcome
Pelvic floor symptoms before and after medical weight loss
Time frame: At least half a year
2 secondary outcomes
To explore the related factors of symptom improvement in pelvic floor dysfunction
Time frame: At least half a year
To explore the improvement of quality of life before and after medical weight loss
Time frame: At least half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 38316600Tian Z, Chen W, Sun Z. Protocol for a prospective longitudinal cohort study on the effects of non-surgical weight loss on pelvic floor dysfunction. BMJ Open. 2024 Feb 5;14(2):e079143. doi: 10.1136/bmjopen-2023-079143.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Pelvic Floor Disorders, run by Peking Union Medical College Hospital at 1 site in China.
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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor symptoms before and after medical weight loss (time frame: At least half a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987085, which also lists 1 linked publication.
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 21 Nov 2023.