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Does prostate size predict the development of incident lower urinary tract symptoms in men with mild to no current symptoms? Results from the REDUCE trial

Simon RM, Howard LE, Moreira DM, Roehrborn C, Vidal AC, Castro-Santamaria R, Freedland SJ.  Eur Urol 2016; 69(5): 885–891

Benign prostatic hyperplasia (BPH) is a common disease with high prevalence in older men, which is associated with lower urinary tract symptoms (LUTS).1 Understanding the causes and risk factors that predict progression of BPH and LUTS may aid prevention of adverse outcomes.1

Prostate size is a known risk factor for BPH and LUTS progression in men with symptoms. However, it is unknown whether prostate size is also a risk factor for incident LUTS in asymptomatic men or those with mild symptoms.1 In a study recently published in European Urology, Simon et al conducted a post-hoc analysis of the REDUCE trial to determine if prostate size was a risk factor for LUTS in men who had previously had mild or no symptoms.1

Prostate size as a risk factor for progression of LUTS

The REDUCE trial was a randomised trial assessing prostate cancer risk reduction with 5 α-reductase inhibitor compared to placebo.1 The study included a considerable proportion of men (n=3090) with mild or no LUTS based on an International Prostate Symptom Score (IPSS) <8.

The authors determined the effects of prostate size on incident LUTS thought to be caused by BPH, defined as:1

  • Two consecutive IPSS values >14
  • Any pharmacological treatment (α-blockers) or surgery for BPH during the study.1

Over the course of the 4-year study, 193/1550 (12.5%) of men in the placebo group with mild-to-no LUTS developed incident LUTS.1

  • 124/193 (64.2%) with prostate size 40.1–80 mL
  • 69/193 (35.8%) with prostate size ≤40.0 mL.1

Of men with mild-to-no LUTS receiving a 5 α-reductase inhibitor, 129/1540 (8.4%) developed incident LUTS.1

  • 70/129 (54.3%) with prostate size 40.1–80 mL
  • 59/129 (45.7%) with prostate size ≤40.0 mL.1

In men with mild-to-no LUTS who received placebo, increased prostate size was associated with incident LUTS.1

Multivariate analysis showed that men in the placebo group with larger prostates (>40.0 mL) had a 67% higher risk of incident LUTS than men with smaller prostates in this group.1

  • Prostate size of 40.1–80 mL compared to ≤40.0 mL, hazard ratio for risk 1.67, 95% confidence interval 1.23–2.26, p=0.01.1

No association was found between prostate size and development of LUTS in men treated with daily 5 α-reductase inhibitor.1

Conclusions

The authors concluded that men with increased prostate size > 40.0 mL with mild or no LUTS were at higher risk of developing LUTS and should be closely monitored. Treatment with 5 α-reductase inhibitors, which are approved for the treatment of BPH, appeared to reduce the risk of incident LUTS in men with increased prostate size.1

Report on: Does prostate size predict the development of incident lower urinary tract symptoms in men with mild to no current symptoms? Results from the REDUCE trial. Simon RM, Howard LE, Moreira DM, Roehrborn C, Vidal AC, Castro-Santamaria R, Freedland SJ.  Eur Urol 2016; 69(5): 885–891.

Reference list

  1. Simon RM, Howard LE, Moreira DM, Roehrborn C, Vidal AC, Castro-Santamaria R, et al. Does prostate size predict the development of incident lower urinary tract symptoms in men with mild to no current symptoms? Results from the REDUCE trial. Eur Urol 2016; 69(5): 885–891.