Results from the reduce trial on the effect of prostate size on incident lower urinary tract symptoms in men with mild to no current symptoms: do they justify prophylactic intervention?

Lower urinary tract symptoms (LUTS) in men constitute a key aspect of urological service delivery. Fundamentally, guidelines focus on the severity of the symptoms, and prioritise management of symptoms according to the extent to which they bother the patient (1). A simple logical approach is to categorise what symptoms are present, whether they are storage (urgency, increased daytime frequency, nocturia), voiding (slow stream, hesitancy) or post voiding (post micturition dribble, sensation of incomplete emptying), and address the particular symptoms impacting on quality of life. In general, mere size of prostate does not suggest the need for intervention; if there are no current LUTS, it is impossible to improve quality of life, while serious adverse events (notably acute urinary retention) are sufficiently rare that a large number of men would have to be treated to prevent one adverse event. The post hoc analysis of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial reported by Simon and colleagues in European Urology (2) potentially provides evidence that could support a modification. Namely, might it be appropriate to consider preventive intervention in asymptomatic men found to have a large prostate? The REDUCE study (Clinical Trials.gov Identifier: NCT00056407) was a four year study comparing safety and effectiveness of dutasteride compared to placebo in preventing the development of prostate cancer in men that were defined as being at an increased risk for prostate cancer. Eligible men were aged 50–75 years, had prostate volume <80 mL, prostate-specific antigen (PSA) of >2.5 ng/mL (50–60 years) or 3.0 (60–75 years) but <10 ng/mL, and a negative prostate biopsy within 6 months of enrolment. The analysis by Simon et al. aimed to determine the effect of prostate size on progression to incident LUTS among men with mild to no LUTS (IPSS <8). In effect, they were evaluating the influence of prostate size on the emergence of symptoms in the 4 years of the study. Overall, 193 out of 1,550 asymptomatic or mildly symptomatic men in the placebo group developed " incident LUTS " , of whom 69 had a prostate size below 40 mL, and 124 above. Incident LUTS was defined as " the first report of medical treatment, surgery, or sustained, clinically significant LUTS ". In itself, this provides useful information: firstly, that many men even with a comparatively large prostate have low severity of LUTS (in this study, 1,357 out of 1,550 men); secondly, that there …