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A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden

A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03903094
Enrollment
6295279
Registered
2019-04-04
Start date
2019-03-07
Completion date
2022-05-06
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder (OAB)

Keywords

anticholinergic burden, anticholinergic, overactive bladder

Brief summary

Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.

Interventions

OTHERNon-Interventional

Overview of anticholinergic burden, rather than to evaluate specific drugs

Sponsors

Astellas Pharma Singapore Pte. Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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).

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.

Design outcomes

Primary

MeasureTime frameDescription
Anticholinergic Cognitive Burden (ACB) score100 daysACB 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.
Korea Specific: Percentage of Participants With any Listed Anticholinergic Use100 daysThis 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.
Korea Specific: Percentage of Participants With Strong Anticholinergic Use100 daysThis 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.
Korea Specific: Number of Anticholinergics Dispensed per Participants100 daysThis 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.
Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort100 daysAttribution 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.

Secondary

MeasureTime frameDescription
Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score100 daysThe attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients.

Countries

Australia, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026