Randomised trials with use of sham is uncommon in the surgical literature, which makes this paper more interesting. Many different treatments are available for treating lower urinary tract symptoms / benign prostatic hyperplasia (LUTS / BPH). Prostatic artery embolisation (PAE) is a relatively new minimally-invasive option for LUTS/BPH. The well-recognised high placebo response to LUT therapy was one reason why the authors conducted the study as a randomised, single-blind, sham-controlled superiority clinical trial. Eighty men were enrolled, 40 randomised to each trial arm. The men were followed up at set intervals (one, three and six months) and after this timeframe, the sham group then underwent PAE and once again followed up with the same intervals. Primary outcomes were measured by use of the International Prostate Symptom Score (IPSS) and Quality of Life (QoL) scores. There was a statistically significant improvement from baseline in the PAE group vs. the sham group. Adverse events occurred in approximately a third of patients in both groups. Although there are several limitations of this study including small sample size and limited follow-up, this study for now is useful in showing that PAE is a feasible option especially for men with prostates over 40cm3 in improving their symptoms for at least 12 months. I have seen PAE being offered to patients with large prostates and with significant haematuria which was refractory to medical treatment. The immediate results following the procedure have shown a marked reduction in their symptoms and with almost complete cessation of haematuria. The long-term outcomes and durability of this intervention remain unknown.
