NCT04412928

Brief Summary

We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
591

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 13, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

May 31, 2020

Last Update Submit

September 14, 2023

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure

    10 year

Secondary Outcomes (1)

  • Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure

    10 years

Interventions

mid-urethral sling procedurePROCEDURE

mid-urethral sling procedure

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with stress urinary incontinence
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women with stress urinary incontinence who underwent mid-urethral sling procedure.

You may qualify if:

  • All women with stress urinary incontinence who underwent mid-urethral sling procedure from January 01, 2008 to July 31, 2019 will be reviewed.

You may not qualify if:

  • Patients undergoing other gynecological operations at the same time, except for cystoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Obstetrics & Gynecology, Associate Professor

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 2, 2020

Study Start

April 13, 2020

Primary Completion

March 12, 2021

Study Completion

April 20, 2021

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)