Last updated: 11/03/2018 16:41:10

Evaluating the impact of early versus delayed 5 alpha reductase inhibitor treatment on the risk of emergent surgery in men with benign prostatic hyperplasia

GSK study ID
114461
See study documents
Clinicaltrials.gov ID
NCT01332487
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants who experienced progression of disease

Timeframe: Up to 5 months

Secondary outcomes:

Number of Participants with the Indicated Time between Acute Urinary Retention and Subsequent Surgery

Timeframe: 6 months

Interventions:
  • Drug: 5ARI + AB
    • Enrollment:
    4068
    Primary completion date:
    2010-11-08
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    August 2010 to August 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Male
    • aged 50 years or older
    • prostate or bladder cancer during the study period
    • any prostate-related surgical procedure within 5 months of the index prescription date
    Inclusion and exclusion criteria
    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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-11-08
    Actual study completion date
    2010-11-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website