NCT05987085

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

August 4, 2023

Last Update Submit

November 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pelvic floor symptoms before and after medical weight loss

    At least half a year

Secondary Outcomes (2)

  • 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

Interventions

Routine intervention included diet control and exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult women seeking medical weight loss

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight LossPelvic Floor Disorders

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

August 3, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations