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NCT Number: NCT03903094

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

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site AU61001, Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

Overview of anticholinergic burden, rather than to evaluate specific drugs

Primary outcomes

  1. 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.

  2. Korea Specific: Percentage of Participants With any Listed Anticholinergic Use

    Time frame: 100 days

    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.

  3. Korea Specific: Percentage of Participants With Strong Anticholinergic Use

    Time frame: 100 days

    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.

  4. Korea Specific: Number of Anticholinergics Dispensed per Participants

    Time frame: 100 days

    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.

  5. Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort

    Time frame: 100 days

    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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Singapore Pte. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2019
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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