Skip to main content
OpenTrials
Completed

NCT Number: NCT03602508

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site AU10000, Sydney, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirabegron

Drug

oral

Other names: YM178, Betmiga

solifenacin

Drug

oral

Other names: YM905, Vesicare

Darifenacin

Drug

oral

imidafenacin

Drug

oral

tolterodine

Drug

oral

Oxybutynin

Drug

oral

trospium

Drug

oral

Fesoterodine

Drug

oral

Propiverine

Drug

oral

Primary outcomes

  1. Patients persistence to the index medication

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Singapore Pte. Ltd.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2018
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.