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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mirabegron | Patients on mirabegron as prescribed by a physician in routine clinical practice. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mirabegron | Drug | oral |
|
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patient (aged ≥18 years; except for Taiwan ≥20 years old) with overactive bladder who received pharmacological treatment between 1st July 2015 and 29th February 2016.
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Singapore Pte. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site AU10000 | Sydney | Australia | ||||
| Site KR82001 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| solifenacin | Drug | oral |
|
|
| darifenacin | Drug | oral |
|
| imidafenacin | Drug | oral |
|
| tolterodine | Drug | oral |
|
| oxybutynin | Drug | oral |
|
| trospium | Drug | oral |
|
| fesoterodine | Drug | oral |
|
| propiverine | Drug | oral |
|
| Up to 12 months |
| Seoul |
| South Korea |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000069464 | Solifenacin Succinate |
| C101207 | darifenacin |
| C120953 | imidafenacin |
| D000068737 | Tolterodine Tartrate |
| C005419 | oxybutynin |
| C003330 | trospium chloride |
| C526675 | fesoterodine |
| C015586 | propiverine |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
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