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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder (OAB)
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 6295279

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Site AU61001
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Site KR82001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Australian and Korean with at least one prescription of any treatment between January 22, 2016 (For Korea: January 1st, 2016) and December 31, 2016 derived from country claims data.

Description

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.

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects With Overactive Bladder Treatment; Subjects who have dispensing records for treatment of overactive bladder will be included	Other: Non-Interventional; Overview of anticholinergic burden, rather than to evaluate specific drugs
Subjects Without Overactive Bladder Treatment; Subjects who do not have dispensing records for treatment of overactive bladder will be included	Other: Non-Interventional; Overview of anticholinergic burden, rather than to evaluate specific drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticholinergic Cognitive Burden (ACB) score	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.	100 days
Korea Specific: Percentage of Participants With any Listed Anticholinergic Use	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.	100 days
Korea Specific: Percentage of Participants With Strong Anticholinergic Use	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.	100 days
Korea Specific: Number of Anticholinergics Dispensed per Participants	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.	100 days
Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort	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.	100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score	The attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients.	100 days

Collaborators and Investigators

• Sponsor: Astellas Pharma Singapore Pte. Ltd.
• Investigators: Study Director: Central Contact, Astellas Pharma Global Development, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: overactive bladder; anticholinergic; anticholinergic burden
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 178-MA-3241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No