Factors Affecting the Cure of Overactive Bladder Syndrome... | NCT04412928

Studies
Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure

NCT04412928

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Sep 15, 2023Actual

Enrollment

591Actual

Phase

Not provided

Conditions

Stress Urinary Incontinence

Interventions

mid-urethral sling procedure

Countries

Taiwan

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2020Actual

Primary Completion Date

Mar 12, 2021Actual

Completion Date

Apr 20, 2021Actual

First Submitted Date

May 31, 2020

First Submission Date that Met QC Criteria

May 31, 2020

First Posted Date

Jun 2, 2020Actual

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

Sep 14, 2023

Last Update Posted Date

Sep 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief of Department of Obstetrics & Gynecology, Associate Professor, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial 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

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

Detailed Description

At present, around 30% of women with stress urinary incontinence have overactive bladder syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors. In addition, we will explore the cure rate and predictors of cure of overactive bladder syndrome after the mid-urethral sling procedure for women with stress urinary incontinence. The above results will be used as a reference for preoperative and postoperative consultation.

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

591Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mid-urethral sling procedure	Procedure	mid-urethral sling procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure		10 year

Secondary Outcomes

Measure	Description	Time Frame
Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with stress urinary incontinence

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital		Banqiao District	New Taipei	22050	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided