CompletedNot Applicable

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

4,068 participantsStarted 2010-08

Plain-language 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).

Who can participate

Age range50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants Who Experienced Progression of Disease

Timeframe: Up to 5 months

Trial details

NCT IDNCT01332487

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-08

Results submitted2012-02-16

View on ClinicalTrials.gov More Prostatic Hyperplasia trials