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OpenTrials
Completed

NCT Number: NCT01332487

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

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).

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5ARI + AB

Drug

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

Primary outcomes

  1. Number of Participants Who Experienced Progression of Disease

    Time frame: 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 outcomes

  1. Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 11, 2011
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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