Clinical trial NCT03903094: A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden
Official title: A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder (OAB)
Keywords: anticholinergic burden
anticholinergic
overactive bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 6295279
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anticholinergic Cognitive Burden (ACB) score
timeFrame: 100 days
measure: Korea Specific: Percentage of Participants With any Listed Anticholinergic Use
timeFrame: 100 days
measure: Korea Specific: Percentage of Participants With Strong Anticholinergic Use
timeFrame: 100 days
measure: Korea Specific: Number of Anticholinergics Dispensed per Participants
timeFrame: 100 days
measure: Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort
timeFrame: 100 days
Secondary outcomes:
measure: Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score
timeFrame: 100 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Site AU61001
city: Seoul
country: Korea, Republic of
facility: Site KR82001
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References: