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PLESS – Proscar Long-term Efficacy and Safety Study

Created: 23/1/2006
Updated: 20/2/2007


The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia.
McConnell, J D et al
NEJM 1998;338:557-563.


  • Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia
  • Extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, is not known


  • PLESS was a 4-year randomised, double-blind, placebo-controlled trial
  • Assesses safety and efficacy of 5mg finasteride vs placebo
  • 3040 men included with moderate to severe symptoms of obstruction (determined by modified AUA score), Qmax <15mls/sec and enlarged prostate on DRE.
  • Patients excluded if A-blockers, anti-androgens, chronic prostatitis, recurrent UTI’s, CaP/Bladder, prostate/bladder surgery, PSA>10 (4-10 included if biopsy NAD) Symptoms, SE’s, flow rates, PSA were evaluated every 4 months
  • Age, symptoms, base-line demographics between groups
  • Complete data on outcomes were available for 2760 men


    • 152(10%) patients in placebo group compared to 69(5%) in finasteride group underwent surgery– Risk reduction of 55%
    • 99(7%) patients in placebo group compared to 42(3%) in finasteride group suffered acute urinary retention– Risk reduction of 57%
    • Symptom score reduced by 3.3 in finasteride group compared to 1.3 in placebo group
    • 18% decrease in mean prostate volume in finasteride group compared to 14% increase in placebo. However, volumes were only performed in 312 patients and change only occurred in 1st year in finasteride group)
    • Flow rates performed at 4 months increased by 1.9 ml/s in finasteride group compared to 0.2ml/s in placebo
    • Increased incidence of sexual SE’s in finasteride compared to placebo (only in 1st year)


    • Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the risk of surgery and acute urinary retention.

    Urology UK Comment:

    • Discontinuation rate – 34% finasteride group 42% placebo (side effects and treatment failure)
    • Although relative risk reductions are high, the absolute risk reduction are not. For example the 4 year absolute risk reduction for retention is 4%-the drug is reducing the risk of an event which is rare

    Associated publications

    Sustained decrease in incidence of acute urinary retention and surgery with finasteride for 6 years in men with benign prostatic hyperplasia.
    Roehrborn CG, Bruskewitz R, Nickel JC, McConnell JD, Saltzman B, Gittelman MC, Malek GH, Gottesman JE, Suryawanshi S, Drisko J, Meehan A, Waldstreicher J; Proscar Long-Term Efficacy and Safety Study Group.
    J Urol. 2004 Mar;171(3):1194-8.

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