Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: 5ARI + AB

• Registration Number: NCT01332487
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Results First Submitted: 2012-02-16
• Results First Submitted QC: 2012-02-16
• Results First Posted: 2012-02-29
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4068

Inclusion Criteria

• Male
• aged 50 years or older
• diagnostic claim for BPH
• prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
• continuously eligible for 6 months prior to and 12 months after index prescription date

Exclusion Criteria

• prostate or bladder cancer during the study period
• any prostate-related surgical procedure within 5 months of the index prescription date
• prescription claim for finasteride 1 mg for male pattern baldness during the study period
• 5ARI therapy prior to initiation of AB therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early initiation of 5ARI therapy	5ARI + AB	Patients starting 5ARI therapy within 30 days of initiating AB therapy
Delayed initiation of 5ARI therapy	5ARI + AB	Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Progression of Disease	Up to 5 months	The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery	6 months