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

NCT03903094 | Completed

• 1 other identifier: 178-MA-3241
• Study Type: observational
• Target: 6,295,279
• Locations: 2 countries
• Sites: 2

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.

Conditions

Overactive Bladder (OAB)

Keywords

anticholinergic burden; anticholinergic; overactive bladder

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score

  100 days

Study Arms (2)

Subjects With Overactive Bladder Treatment

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

Other: Non-Interventional

Subjects Without Overactive Bladder Treatment

Subjects who do not have dispensing records for treatment of overactive bladder will be included

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Overview of anticholinergic burden, rather than to evaluate specific drugs

Subjects With Overactive Bladder Treatment; Subjects Without Overactive Bladder Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (2)

Site AU61001

Melbourne, Australia

Location

Site KR82001

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Central Contact

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 4, 2019
• Study Start: March 7, 2019
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); KR (1)