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Characteristics of medications for the treatment of lower urinary tract symptoms after midurethral sling in women

Status Approved

First Submitted Date

2021/01/05
Registered Date

2021/01/25
Last Updated Date

2021/01/05

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005821
Unique Protocol ID	CR319343
Public/Brief Title	Characteristics of medications for the treatment of lower urinary tract symptoms after midurethral sling in women
Scientific Title	Characteristics of medications for the treatment of lower urinary tract symptoms after midurethral sling in women
Acronym	CMTM
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CR319343
Approval Date	2019-10-08
Institutional Review Board Name	Yonsei University Wonju Severance Christian Hospital Institutional Review Board
Institutional Review Board Address	20, Ilsan-ro, Wonju-si, Gangwon-do
Institutional Review Board Telephone	033-741-1703
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Su Jin Kim
Title	Associate Professor
Telephone	+82-33-741-1347
Affiliation	Yonsei University, Wonju Severance Christian Hospital
Address	Yonsei University, Wonju Severance Christian Hospital
Contact Person for Public Queries
Name	Su Jin Kim
Title	Associate Professor
Telephone	+82-33-741-1347
Affiliation	Yonsei University, Wonju Severance Christian Hospital
Address	Yonsei University, Wonju Severance Christian Hospital
Contact Person for Updating Information
Name	Su Jin Kim
Title	Associate Professor
Telephone	+82-33-741-1347
Affiliation	Yonsei University, Wonju Severance Christian Hospital
Address	Yonsei University, Wonju Severance Christian Hospital

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-10-01 Actual
Target Number of Participant	373716
Primary Completion Date	2021-01-04 , Actual
Study Completion Date	2021-01-04 , Actual
Name of Study	Yonsei University, Wonju Severance Christian Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-10-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yonsei University, Wonju Severance Christian Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University, Wonju Severance Christian Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	- Stress urinary incontinence (SUI) is a common voiding problem noted in middle-aged women. And midurethral sling is a standard treatment method for stress urinary incontinence. -Women with SUI commonly have other types of voiding problems such as the overactive bladder (OAB), urge urinary incontinence, or nocturia. According to an EPIC study, about 50% of OAB women showed urinary incontinence. And 28.6% of OAB women showed SUI. Especially 38.1% of OAB women showed both SUI and urge urinary incontinence. We could know that OAB and urge urinary incontinence are commonly noted in women with SUI from these results. -Persistent bothersome lower urinary tract symptoms (LUTS) after midurethral sling is a factor in decreasing patient satisfaction. Previous studies showed that preoperative LUTS such as urinary frequency, urge urinary incontinence might be associated with low postoperative satisfaction after midurethral sling. -However, the study about the role of preoperative LUTS in the women received midurethral sling have been lacking. -Therefore, we plan to analyze the preoperative factor influencing the result after midurethral sling from the National-level data from the National Health Insurance Service and National Statistical Office. -Objectives: Women (over 20 years old) with stress urinary incontinence and received midurethral sling during 2007-2018 from the National-level data from the National Health Insurance Service and National Statistical Office -Methods: Evaluate the treatment pattern through specific code for the disease, operation, or medication.

Study Summary Information

Lay Summary

- Stress urinary incontinence (SUI) is a common voiding problem noted in middle-aged women. And midurethral sling is a standard treatment method for stress urinary incontinence.

-Women with SUI commonly have other types of voiding problems such as the overactive bladder (OAB), urge urinary incontinence, or nocturia. According to an EPIC study, about 50&#37; of OAB women showed urinary incontinence. And 28.6&#37; of OAB women showed SUI. Especially 38.1&#37; of OAB women showed both SUI and urge urinary incontinence. We could know that OAB and urge urinary incontinence are commonly noted in women with SUI from these results.

-Persistent bothersome lower urinary tract symptoms (LUTS) after midurethral sling is a factor in decreasing patient satisfaction. Previous studies showed that preoperative LUTS such as urinary frequency, urge urinary incontinence might be associated with low postoperative satisfaction after midurethral sling.

-However, the study about the role of preoperative LUTS in the women received midurethral sling have been lacking.

-Therefore, we plan to analyze the preoperative factor influencing the result after midurethral sling from the National-level data from the National Health Insurance Service and National Statistical Office.

-Objectives: Women (over 20 years old) with stress urinary incontinence and received midurethral sling during 2007-2018 from the National-level data from the National Health Insurance Service and National Statistical Office

-Methods: Evaluate the treatment pattern through specific code for the disease, operation, or medication.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	373716
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Women received midurethral sling
Cohort/ Group 1	Cohort/Group Description Women (over 20 years old) with stress urinary incontinence and received midurethral sling during 2007-2018 from the National-level data from the National Health Insurance Service and National Statistical Office
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Women over 20 years old
Sampling Method	Women with stress urinary incontinence and received midurethral sling from the National-level data from the National Health Insurance Service and National Statistical Office
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N39.3)Stress incontinence Urinary Incontinence, Stress
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 20Year~100Year
	Description Women with stress urinary incontinence and received midurethral sling
Exclusion Criteria	men
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Treatment with urologic medication or not
Timepoint	Within 1 year after midurethral sling
Secondary Outcome(s) 1
Outcome	Recurrence of stress urinary incontinence
Timepoint	Within 1 year after midurethral sling

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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