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Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01381510
Enrollment
54459
Registered
2011-06-27
Start date
2010-06-30
Completion date
2010-08-31
Last updated
2012-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasia, Adherence, Acute urinary retention, Enlarged prostate, 5-alpha reductase inhibitor, Surgery, Cost and cost analysis

Brief summary

Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs. The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters. The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009. This study is a retrospective cohort analysis of medical claims data.

Interventions

DRUG5-alpha Reductase Inhibitor (5ARI)

A 5ARI: Either dutasteride or finisteride

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male * Aged 50 years or older * A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification \[ICD-9-CM\] codes 222.2x or 600.xx) * A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period * Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription

Exclusion criteria

* A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46) * A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51), * A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date * A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after the index date

Design outcomes

Primary

MeasureTime frameDescription
The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgeryOne year following the first date of 5ARI therapyThe occurence of a code for either AUR or prostate surgery will be identified for patients who were adherent with 5ARI therapy as measured with a medication possession ratio (MPR)

Secondary

MeasureTime frameDescription
Mean costs associated with AUR or prostate surgeryOne year following the first date of 5ARI therapyThe mean costs of outpatient and inpatient visits associated with the diagnosis code for AUR or the procedure codes for prostate surgery will be compared between patients who were compliant with 5ARI therapy and those who were not

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026