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

NCT03602508 | Completed

• 1 other identifier: 178-MA-3147
• Study Type: observational
• Target: 5,589
• Locations: 2 countries
• Sites: 2

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.

Conditions

Overactive Bladder (OAB)

Keywords

darifenacin; fesoterodine; trospium; solifenacin; oxybutynin; tolterodine; Betmiga; YM178; mirabegron; Overactive bladder; propiverine; antimuscarinics; OAB; imidafenacin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patients persistence to the overall Overactive Bladder (OAB) treatment regardless of treatment switching to other OAB medications

  Up to 12 months

Study Arms (2)

mirabegron

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

Drug: mirabegron

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; Drug: darifenacin; Drug: imidafenacin; Drug: tolterodine; Drug: oxybutynin; Drug: trospium; Drug: fesoterodine; Drug: propiverine

Interventions

mirabegron DRUG

oral

Also known as: YM178, Betmiga

mirabegron

solifenacin DRUG

oral

Also known as: YM905, Vesicare

antimuscarinics

darifenacin DRUG

oral

antimuscarinics

imidafenacin DRUG

oral

antimuscarinics

tolterodine DRUG

oral

antimuscarinics

oxybutynin DRUG

oral

antimuscarinics

trospium DRUG

oral

antimuscarinics

fesoterodine DRUG

oral

antimuscarinics

propiverine DRUG

oral

antimuscarinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient with a new prescription of the index medication within the index period;
• Patient received orally administered monotherapy for OAB on index date.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (2)

Site AU10000

Sydney, Australia

Location

Site KR82001

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; Solifenacin Succinate; darifenacin; imidafenacin; Tolterodine Tartrate; oxybutynin; trospium chloride; fesoterodine; propiverine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Central Contact

  Astellas Pharma Singapore Pte. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: July 20, 2018
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: October 16, 2024

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); KR (1)