Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

NCT ID: NCT03602508

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-20

Study Completion Date

2019-09-13

Brief Summary

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The purpose of this study is to descriptively evaluate the persistence among adults treated with mirabegron or antimuscarinics in Australia, South Korea and Taiwan.

This study will also assess the persistence to the overall Overactive bladder (OAB) treatments of a patient, regardless of treatment discontinuation or switch to other OAB medications.

Detailed Description

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This study is entirely descriptive using secondary medical claim and pharmacy prescription data. No formal comparisons between users of mirabegron and antimuscarinic will be made. Furthermore, no a priori hypothesis testing is intended.

Conditions

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Overactive Bladder (OAB)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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mirabegron

Patients on mirabegron as prescribed by a physician in routine clinical practice.

mirabegron

Intervention Type DRUG

oral

antimuscarinics

Patients on one of the following antimuscarinics: solifenacin, darifenacin, imidafenacin, tolterodine, oxybutynin, trospium, fesoterodine or propiverine as prescribed by a physician in routine clinical practice.

solifenacin

Intervention Type DRUG

oral

darifenacin

Intervention Type DRUG

oral

imidafenacin

Intervention Type DRUG

oral

tolterodine

Intervention Type DRUG

oral

oxybutynin

Intervention Type DRUG

oral

trospium

Intervention Type DRUG

oral

fesoterodine

Intervention Type DRUG

oral

propiverine

Intervention Type DRUG

oral

Interventions

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mirabegron

oral

Intervention Type DRUG

solifenacin

oral

Intervention Type DRUG

darifenacin

oral

Intervention Type DRUG

imidafenacin

oral

Intervention Type DRUG

tolterodine

oral

Intervention Type DRUG

oxybutynin

oral

Intervention Type DRUG

trospium

oral

Intervention Type DRUG

fesoterodine

oral

Intervention Type DRUG

propiverine

oral

Intervention Type DRUG

Other Intervention Names

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YM178 Betmiga YM905 Vesicare

Eligibility Criteria

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Inclusion Criteria

* Patient with a new prescription of the index medication within the index period;
* Patient received orally administered monotherapy for OAB on index date.

Exclusion Criteria

* Patient with prior dispensing record of the index medication during the pre-index period;
* Patient received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment between the pre index and post-index period;
* Patient diagnosed with stress incontinence (International Classification of Diseases-10 (ICD-10) N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) before index date;
* Patient with urinary tract infection (ICD-10 N30.0 or equivalent) (for National Health Insurance Research Database (NHIRD) and Health Insurance Review and Assessment (HIRA) database) or a co-prescription of any antibiotics (for NostraData) on index date.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Singapore Pte. Ltd.

Locations

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Site AU10000

Sydney, , Australia

Site Status

Site KR82001

Seoul, , South Korea

Site Status

Countries

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Australia South Korea

Other Identifiers

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178-MA-3147

Identifier Type: -

Identifier Source: org_study_id

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