title: 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.
abstract: It has been shown that increased prostate size is a risk factor for lower urinary tract symptom (LUTS) progression in men who currently have LUTS presumed due to benign prostatic hyperplasia (BPH).
  
  
  
  To determine if prostate size is a risk factor for incident LUTS in men with mild to no symptoms.
  
  
  
  We conducted a post hoc analysis of the REDUCE study, which contained a substantial number of men (n=3090) with mild to no LUTS (International Prostate Symptom Score [IPSS] <8).
  
  
  
  Our primary outcome was determination of the effect of prostate size on incident LUTS presumed due to BPH defined as two consecutive IPSS values >14, or receiving any medical (α-blockers) or surgical treatment for BPH throughout the study course. To determine the risk of developing incident LUTS, we used univariable and multivariable Cox models, as well as Kaplan-Meier curves and the log-rank test.
  
  
  
  Among men treated with placebo during the REDUCE study, those with a prostate size of 40.1-80ml had a 67% higher risk (hazard risk 1.67, 95% confidence interval 1.23-2.26, p=0.001) of developing incident LUTS compared to men with a prostate size 40.0ml or smaller. There was no association between prostate size and risk of incident LUTS in men treated with 0.5mg of dutasteride. The post hoc nature of our study design is a potential limitation.
  
  
  
  Men with mild to no LUTS but increased prostate size are at higher risk of incident LUTS presumed due to BPH. This association was negated by dutasteride treatment.
  
  
  
  Benign prostatic hyperplasia (BPH) is a very common problem among older men, which often manifests as lower urinary tract symptoms (LUTS), and can lead to potentially serious side effects. In our study we determined that men with mild to no current LUTS but increased prostate size are much more likely to develop LUTS presumed due to BPH in the future. This association was not seen in men treated with dutasteride, a drug approved for treatment of BPH. Our study reveals that men with a prostate size of 40.1-80ml are potential candidates for closer follow-up.
authors.affiliation: Duke Prostate Center, Division of Urology, Department of Surgery and Pathology, Duke University School of Medicine, Durham, NC, USA; Urology Section, Veterans Affairs Medical Center, Durham, NC, USA.
authors.forename: Ross M
authors.initials: RM
authors.lastname: Simon
authors.affiliation: Urology Section, Veterans Affairs Medical Center, Durham, NC, USA; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Howard
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Moreira
authors.affiliation: Department of Urology, UT Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Claus
authors.initials: C
authors.lastname: Roehrborn
authors.affiliation: Department of Surgery, Division of Urology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Adriana C
authors.initials: AC
authors.lastname: Vidal
authors.affiliation: Metabolic Pathways and Cardiovascular R&D Unit, GlaxoSmithKline, King of Prussia, PA, USA.
authors.forename: Ramiro
authors.initials: R
authors.lastname: Castro-Santamaria
authors.affiliation: Urology Section, Veterans Affairs Medical Center, Durham, NC, USA; Department of Surgery, Division of Urology, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: stephen.freedland@cshs.org.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Freedland
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000627:therapeutic use; D000368:Aged; D000068538:Dutasteride / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D059411:Lower Urinary Tract Symptoms / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011467:Prostate / Q000473:pathology*; D011468:Prostatectomy; D011470:Prostatic Hyperplasia / Q000473:pathology* / Q000628:therapy; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D014481:United States / Q000453:epidemiology
chemical_list: D058891:5-alpha Reductase Inhibitors; D000068538:Dutasteride
keywords: Lower urinary tract symptoms; Prostate; Prostatic hyperplasia; Treatment