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Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects With Overactive Bladder Treatment | Subjects who have dispensing records for treatment of overactive bladder will be included |
| |
| Subjects Without Overactive Bladder Treatment | Subjects who do not have dispensing records for treatment of overactive bladder will be included |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Overview of anticholinergic burden, rather than to evaluate specific drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anticholinergic Cognitive Burden (ACB) score | ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X…)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient. | 100 days |
| Korea Specific: Percentage of Participants With any Listed Anticholinergic Use | This will be calculated as number of participants with any listed anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100. | 100 days |
| Korea Specific: Percentage of Participants With Strong Anticholinergic Use | This will be calculated as number of participants with strong anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100. | 100 days |
| Korea Specific: Number of Anticholinergics Dispensed per Participants | This will be calculated as total number of anticholinergics dispensed divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100. | 100 days |
| Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort | Attribution proportion of OAB medication to total ACB will be calculated as the ratio between the sum over all OAB patients of the ACB scores of each OAB medication multiplied by the number of days supply in the numerator and the sum over all OAB patients of the ACB scores of each antimuscarinic medication multiplied by the number of days supply in the denominator. |
| Measure | Description | Time Frame |
|---|---|---|
| Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score | The attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients. | 100 days |
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Inclusion Criteria:
Inclusion Criteria for Korea:
Exclusion Criteria:
Exclusion Criteria for Korea:
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Australian and Korean with at least one prescription of any treatment between January 22, 2016 (For Korea: January 1st, 2016) and December 31, 2016 derived from country claims data.
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site AU61001 | Melbourne | 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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| 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 |
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| 100 days |
| Seoul |
| South Korea |
| 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 |