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

Overactive Bladder (OAB) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602508
• Other study ID #: 178-MA-3147
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: September 13, 2019

Study information

• Verified date: October 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5589
• Est. completion date: September 13, 2019
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Drug:
• mirabegron
oral
• solifenacin
oral
• darifenacin
oral
• imidafenacin
oral
• tolterodine
oral
• oxybutynin
oral
• trospium
oral
• fesoterodine
oral
• propiverine
oral

Locations

Country	Name	City	State
Australia	Site AU10000	Sydney
Korea, Republic of	Site KR82001	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Singapore Pte. Ltd.

Countries where clinical trial is conducted

Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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