OBJECTIVES: To investigate the complication rate within 30 days after transrectal ultrasound-guided biopsy of the prostate in England, and to examine associated risk factors. METHODS: A population-based study was carried out using the English cancer registry linked to administrative hospital data. We included men aged 45 years and older diagnosed with prostate cancer between 2000 and 2008. A complication was considered to have occurred if men had been admitted to hospital as a result of urological causes (urinary tract infection/sepsis, hematuria and urinary retention) within 30 days of the transrectal ultrasound-guided biopsy of the prostate. Multivariable logistic regression was carried out to estimate odds ratios, reflecting the impact of risk factors on the complication rate. RESULTS: Of the 198,361 included men, 69% were aged between 65 and 84 years. The 30-day complication rate was 3.7% (1.1% for urinary tract infection/sepsis, 1.4% for hematuria and 1.3% for urinary retention). The most important risk factors were age above 85 years (odds ratio 3.85, 95% confidence interval 3.18-4.67, compared with age below 55 years) and three or more comorbidities (odds ratio 3.50, 95% confidence interval 3.17-5.87, compared with no comorbidity). The overall complication rate increased over time (odds ratio 1.20, 95% confidence interval 1.08-1.34, 2008 compared with 2000), as did the complication rate as a result of urinary tract infection/sepsis (odds ratio 1.72, 95% confidence interval 1.41-2.10, 2008 compared with 2000). CONCLUSIONS: There has been an increase in the complication rate after transrectal ultrasound-guided biopsy of the prostate in England between 2000 and 2008, predominantly as a result of infections. Age and comorbid conditions seem to represent the two most important risk factors for occurrence of post-biopsy complications.