Effects of Testosterone Replacement Therapy on Lower Urinary Tract Symptoms: A Systematic Review and Meta-analysis

Eur Urol. 2016 Jun;69(6):1083-90. doi: 10.1016/j.eururo.2016.01.043. Epub 2016 Feb 11.


Context: There is a potential risk that testosterone replacement therapy (TRT) may exacerbate lower urinary tract symptoms (LUTS) among aging men with late-onset hypogonadism (LOH) because of testosterone's growth-promoting effects on the prostate.

Objective: To compare the change in LUTS severity as assessed using the International Prostate Symptom Score (IPSS) between men receiving TRT versus placebo for the treatment of LOH.

Evidence acquisition: Systematic search of MEDLINE, Embase, ClinicalTrials.gov, and The Cochrane Library for randomized controlled trials of TRT for LOH published between January 1992 and September 2015. Studies were eligible for inclusion if they were a randomized control trial, used TRT, and assessed LUTS outcomes using the IPSS. Estimates were pooled using random effects meta-analysis. Differences by study-level characteristics were estimated using meta-regression.

Evidence synthesis: Data were extracted from 14 trials involving 2029 participants. The average age was 64.5 yr and the average follow-up was 34.4 mo. Seven studies used topical, five used injectable, and two used oral testosterone. There was no statistically significant difference in pooled changes in IPSS from baseline to follow up in men treated with TRT compared with those receiving placebo (-0.41 points [95% confidence interval: -0.89 to 0.07; I(2)=0%, p=0.28] vs. 0.12 points [95% confidence interval: -0.32 to 0.55; I(2)=0%, p=0.81], between-group difference p>0.05). No between-group differences were noted in subanalyses that controlled for potential confounders such as type of testosterone, change in testosterone, aging male symptom scale, or prostate-specific antigen levels (p>0.05 for all comparisons).

Conclusions: In this meta-analysis of 14 clinical trials of TRT for LOH, the change in IPSS was similar among men receiving TRT versus placebo, suggesting that TRT treatment does not worsen LUTS among men with LOH.

Patient summary: In this analysis of 14 clinical trials, testosterone replacement therapy did not worsen lower urinary tract symptoms among men being treated for late-onset hypogonadism.

Keywords: Benign prostatic hyperplasia; Hypogonadism; Lower urinary tract symptoms; Meta-analysis; Prostate; Testosterone.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Androgens / adverse effects*
  • Clinical Trials as Topic
  • Hormone Replacement Therapy / adverse effects*
  • Humans
  • Hypogonadism / drug therapy
  • Lower Urinary Tract Symptoms / chemically induced*
  • Male
  • Severity of Illness Index
  • Testosterone / adverse effects*


  • Androgens
  • Testosterone