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

NCT ID: NCT03903094

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6295279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-07

Study Completion Date

2022-05-06

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder (OAB)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects With Overactive Bladder Treatment

Subjects who have dispensing records for treatment of overactive bladder will be included

Non-Interventional

Intervention Type OTHER

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

Non-Interventional

Intervention Type OTHER

Overview of anticholinergic burden, rather than to evaluate specific drugs

Interventions

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Non-Interventional

Overview of anticholinergic burden, rather than to evaluate specific drugs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* 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.


* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

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Site AU61001

Melbourne, , Australia

Site Status

Site KR82001

Seoul, , South Korea

Site Status

Countries

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Australia South Korea

Other Identifiers

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178-MA-3241

Identifier Type: -

Identifier Source: org_study_id

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