Trial Outcomes & Findings for Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia (NCT NCT01334723)

Results Overview

Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio \[MPR\]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.

Recruitment status

COMPLETED

Target enrollment

35032 participants

Primary outcome timeframe

The 5 and a half year period from January 1, 2000 to June 30, 2006

Results posted on

2017-05-30

Participant Flow

The study utilized retrospective claims data from the Integrated Healthcare HealthCare Information Services, Inc. (IHCIS) database, a nationally representative managed care database that represents over 30 healthplans and more than 25 million lives.

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.

Participant milestones

Participant milestones
Measure	Acute Urinary Retention Outcomes Cohort This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.	Prostate Surgery Outcomes Cohort This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
Overall Study STARTED	17293	17739
Overall Study COMPLETED	17293	17739
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Urinary Retention Outcomes Cohort n=17293 Participants This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.	Prostate Surgery Outcomes Cohort n=17739 Participants This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.	Total n=35032 Participants Total of all reporting groups
Age, Customized Age >= 50	17293 participants n=5 Participants	17739 participants n=7 Participants	35032 participants n=5 Participants
Age, Customized Age < 50	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	17293 Participants n=5 Participants	17739 Participants n=7 Participants	35032 Participants n=5 Participants

PRIMARY outcome

Timeframe: The 5 and a half year period from January 1, 2000 to June 30, 2006

Population: Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery.

Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio \[MPR\]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.