Medical Weight Loss on Pelvic Floor Dysfunction | NCT05987085

Studies
Medical Weight Loss on Pelvic Floor Dysfunction

NCT05987085

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Nov 21, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Weight Loss
Pelvic Floor Disorders

Interventions

Diet and exercise

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2023Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Aug 4, 2023

First Submission Date that Met QC Criteria

Aug 4, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2023

Last Update Posted Date

Nov 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhijing Sun, Professor, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diet and exercise	Other	Routine intervention included diet control and exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pelvic floor symptoms before and after medical weight loss		At least half a year

Secondary Outcomes

Measure	Description	Time Frame
To explore the related factors of symptom improvement in pelvic floor dysfunction		At least half a year
To explore the improvement of quality of life before and after medical weight loss		At least half a year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult women seeking medical weight loss

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38316600	Derived	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.

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004032	Diet
D015444	Exercise

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D009043	Motor Activity