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临床试验/NCT01332487
NCT01332487已完成不适用

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

GlaxoSmithKline0 个研究点目标入组 4,068 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
4,068
主要终点
Number of Participants Who Experienced Progression of Disease

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Early initiation of 5ARI therapy

Patients starting 5ARI therapy within 30 days of initiating AB therapy

干预措施: 5ARI + AB (Drug)

Delayed initiation of 5ARI therapy

Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy

干预措施: 5ARI + AB (Drug)

结局指标

主要结局

Number of Participants Who Experienced Progression of Disease

时间窗: 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.

次要结局

  • Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

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