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

Sponsor

Astellas Pharma Singapore Pte. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03602508

Collaborator

(none)

5,589

Enrollment

Locations

13.8

Actual Duration (Months)

2794.5

Patients Per Site

202.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder (OAB)	Drug: mirabegron Drug: solifenacin Drug: darifenacin Drug: imidafenacin Drug: tolterodine Drug: oxybutynin Drug: trospium Drug: fesoterodine Drug: propiverine

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

5589 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 20, 2018

Actual Primary Completion Date :

Sep 13, 2019

Actual Study Completion Date :

Sep 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
mirabegron Patients on mirabegron as prescribed by a physician in routine clinical practice.	Drug: mirabegron oral Other Names: YM178 Betmiga
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.	Drug: solifenacin oral Other Names: YM905 Vesicare Drug: darifenacin oral Drug: imidafenacin oral Drug: tolterodine oral Drug: oxybutynin oral Drug: trospium oral Drug: fesoterodine oral Drug: propiverine oral

Arm

Intervention/Treatment

mirabegron

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

Drug: mirabegron

oral

Other Names:

YM178

Betmiga

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.

Drug: solifenacin

oral

Other Names:

YM905

Vesicare

Drug: darifenacin

oral

Drug: imidafenacin

oral

Drug: tolterodine

oral

Drug: oxybutynin

oral

Drug: trospium

oral

Drug: fesoterodine

oral

Drug: propiverine

oral

Outcome Measures

Primary Outcome Measures

Patients persistence to the index medication [Up to 12 months]
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.

Secondary Outcome Measures

Patients persistence to the overall Overactive Bladder (OAB) treatment regardless of treatment switching to other OAB medications [Up to 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.