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

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Astellas

Status

Completed

Conditions

Overactive Bladder (OAB)

Treatments

Other: Non-Interventional

Study type

Observational

Funder types

Industry

Identifiers

NCT03903094
178-MA-3241

Details and patient eligibility

About

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.

Enrollment

6,295,279 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

6,295,279 participants in 2 patient groups

Subjects With Overactive Bladder Treatment
Description:
Subjects who have dispensing records for treatment of overactive bladder will be included
Treatment:
Other: Non-Interventional
Subjects Without Overactive Bladder Treatment
Description:
Subjects who do not have dispensing records for treatment of overactive bladder will be included
Treatment:
Other: Non-Interventional

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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