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

Overactive Bladder (OAB) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903094
• Other study ID #: 178-MA-3241
• Status: Completed
• Start date: March 7, 2019
• Est. completion date: May 6, 2022

Study information

• Verified date: May 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6295279
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Other:
• Non-Interventional
Overview of anticholinergic burden, rather than to evaluate specific drugs

Locations

Country	Name	City	State
Australia	Site AU61001	Melbourne
Korea, Republic of	Site KR82001	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Singapore Pte. Ltd.

Countries where clinical trial is conducted

Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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