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

Study Overview
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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.

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

Conditions
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Overactive Bladder (OAB)

Intervention / Treatment
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* Drug: mirabegron
* Drug: solifenacin
* Drug: darifenacin
* Drug: imidafenacin
* Drug: tolterodine
* Drug: oxybutynin
* Drug: trospium
* Drug: fesoterodine
* Drug: propiverine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mirabegron<br>Patients on mirabegron as prescribed by a physician in routine clinical practice. | Drug: mirabegron<br>* oral<br>* Other names: Betmiga;|
| antimuscarinics<br>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. | Drug: solifenacin<br>* oral<br>* Other names: Vesicare;Drug: darifenacin<br>* oral<br>Drug: imidafenacin<br>* oral<br>Drug: tolterodine<br>* oral<br>Drug: oxybutynin<br>* oral<br>Drug: trospium<br>* oral<br>Drug: fesoterodine<br>* oral<br>Drug: propiverine<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients persistence to the index medication | Persistence to the index medication (i.e. mirabegron; solifenacin; darifenacin; imidafenacin; tolterodine; oxybutynin; trospium; fesoterodine; propiverine) is defined as the time to discontinuation during the 1 year post-index period. Days with the index medication for each patient will be calculated as the sum of days of supply per prescription. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients persistence to the overall Overactive Bladder (OAB) treatment regardless of treatment switching to other OAB medications | Time to discontinuation of the overall OAB treatment during the one-year post-index period (persistence) is defined as days with the index medication (i.e. mirabegron; solifenacin; darifenacin; imidafenacin; tolterodine; oxybutynin; trospium; fesoterodine; propiverine) for each patient and days' supply of any OAB medication will be added up until the grace period exceeds 30 days. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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darifenacin, fesoterodine, trospium, solifenacin, oxybutynin, tolterodine, Betmiga, YM178, mirabegron, Overactive bladder, propiverine, antimuscarinics, OAB, imidafenacin