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

Overview

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.

Full Title of Study: “A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 31, 2022

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Anticholinergic Cognitive Burden (ACB) score
    • Time Frame: 100 days
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016. 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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Singapore Pte. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Central Contact, Study Director, Astellas Pharma Global Development, Inc.

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