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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder (OAB)
• Intervention / Treatment: Drug: solifenacin; Drug: mirabegron; 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 Type: Observational
• Enrollment (Actual): 5589

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Site AU10000
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Site KR82001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Vesicare; YM905; Drug: darifenacin; oral; Drug: imidafenacin; oral; Drug: tolterodine; oral; Drug: oxybutynin; oral; Drug: trospium; oral; Drug: fesoterodine; oral; Drug: propiverine; oral

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Singapore Pte. Ltd.
• Investigators: Study Director: Central Contact, Astellas Pharma Singapore Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): September 13, 2019
• Study Completion (Actual): September 13, 2019

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: oxybutynin; OAB; solifenacin; YM178; mirabegron; Betmiga; Overactive bladder; darifenacin; fesoterodine; trospium; tolterodine; propiverine; antimuscarinics; imidafenacin
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Oxybutynin; Darifenacin; Mirabegron; Solifenacin Succinate; Tolterodine Tartrate; Fesoterodine; Propiverine
• Other Study ID Numbers: 178-MA-3147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Phase 1 trial in healthy volunteers, phase 1 trial in volunteers with renal/hepatic impairment or non-interventional (observational) trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No