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NCT01332487 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01332487
Other study ID # 114461
Secondary ID
Status Completed
Phase N/A
First received April 7, 2011
Last updated February 16, 2012
Start date August 2010
Est. completion date August 2010

Study information
Verified date September 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: No Health Authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 4068
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• 5ARI + AB
5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Who Experienced Progression of Disease 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. Up to 5 months No
Secondary Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery 6 months No
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