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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03903094




Registration number
NCT03903094
Ethics application status
Date submitted
25/03/2019
Date registered
4/04/2019
Date last updated
31/10/2024

Titles & IDs
Public title
A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden
Scientific title
A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea
Secondary ID [1] 0 0
178-MA-3241
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
Other interventions - Non-Interventional

Subjects With Overactive Bladder Treatment - Subjects who have dispensing records for treatment of overactive bladder will be included

Subjects Without Overactive Bladder Treatment - Subjects who do not have dispensing records for treatment of overactive bladder will be included


Other interventions: Non-Interventional
Overview of anticholinergic burden, rather than to evaluate specific drugs
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anticholinergic Cognitive Burden (ACB) score
Assessment method [1] 0 0
ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X...)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient.
Timepoint [1] 0 0
100 days
Primary outcome [2] 0 0
Korea Specific: Percentage of Participants With any Listed Anticholinergic Use
Assessment method [2] 0 0
This will be calculated as number of participants with any listed anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Timepoint [2] 0 0
100 days
Primary outcome [3] 0 0
Korea Specific: Percentage of Participants With Strong Anticholinergic Use
Assessment method [3] 0 0
This will be calculated as number of participants with strong anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Timepoint [3] 0 0
100 days
Primary outcome [4] 0 0
Korea Specific: Number of Anticholinergics Dispensed per Participants
Assessment method [4] 0 0
This will be calculated as total number of anticholinergics dispensed divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Timepoint [4] 0 0
100 days
Primary outcome [5] 0 0
Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort
Assessment method [5] 0 0
Attribution proportion of OAB medication to total ACB will be calculated as the ratio between the sum over all OAB patients of the ACB scores of each OAB medication multiplied by the number of days supply in the numerator and the sum over all OAB patients of the ACB scores of each antimuscarinic medication multiplied by the number of days supply in the denominator.
Timepoint [5] 0 0
100 days
Secondary outcome [1] 0 0
Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score
Assessment method [1] 0 0
The attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients.
Timepoint [1] 0 0
100 days

Eligibility
Key inclusion criteria
* Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016.

Inclusion Criteria for Korea:

* Have at least one dispensing of any medication between January 1st, 2016 and December 31, 2016.
* Participant was diagnosed with OAB (ICD-10 N32.8, N31.0, N31.1, N31.2, N31.8, N31.9, N32.9, N39.8 and N39.40) at index date.
* Participant did not have dispensing record of an OAB medication during the washout period (6 months prior to the index date).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who do not have a complete year of data availability in the database prior to index date.
* Have record of hospitalization on the index date.

Exclusion Criteria for Korea:

* Participant was hospitalized on the index date.
* Participant did not have an active insurance status during the washout period or on the index date.
* Participant received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment during the washout period.
* Participant was diagnosed with stress incontinence (ICD-10 N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) during the washout period.
* Participant was diagnosed with urinary tract infection (ICD-10 N30.0 and N39.0 or equivalent) during the washout period or on the 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
7/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2022
Sample size
Target
Accrual to date
Final
6295279
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site AU61001 - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
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 Global Development, Inc.
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/NCT03903094