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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03602508




Registration number
NCT03602508
Ethics application status
Date submitted
19/07/2018
Date registered
27/07/2018

Titles & IDs
Public title
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
Scientific title
Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
Secondary ID [1] 0 0
178-MA-3147
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder (OAB) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - mirabegron
Treatment: Drugs - solifenacin
Treatment: Drugs - darifenacin
Treatment: Drugs - imidafenacin
Treatment: Drugs - tolterodine
Treatment: Drugs - oxybutynin
Treatment: Drugs - trospium
Treatment: Drugs - fesoterodine
Treatment: Drugs - propiverine

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

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.


Treatment: Drugs: mirabegron
oral

Treatment: Drugs: solifenacin
oral

Treatment: Drugs: darifenacin
oral

Treatment: Drugs: imidafenacin
oral

Treatment: Drugs: tolterodine
oral

Treatment: Drugs: oxybutynin
oral

Treatment: Drugs: trospium
oral

Treatment: Drugs: fesoterodine
oral

Treatment: Drugs: propiverine
oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patients persistence to the index medication
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Patients persistence to the overall Overactive Bladder (OAB) treatment regardless of treatment switching to other OAB medications
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2019
Sample size
Target
Accrual to date
Final
5589
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site AU10000 - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Singapore Pte. Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Central Contact
Address 0 0
Astellas Pharma Singapore Pte. Ltd.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03602508