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

Study Overview
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Brief Summary
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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).

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

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: 5ARI + AB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early initiation of 5ARI therapy<br>Patients starting 5ARI therapy within 30 days of initiating AB therapy | Drug: 5ARI + AB<br>* 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin<br>|
| Delayed initiation of 5ARI therapy<br>Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy | Drug: 5ARI + AB<br>* 5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-alpha-reductase inhibitor, prostate surgery, alpha-blocker, enlarged prostate, acute urinary retention, Benign prostatic hyperplasia