Aquablation for benign prostatic hyperplasia: real-world prostate size relevance and bleeding events across 6 years

To present large-scale safety outcomes, with a particular focus on postoperative bleeding following Aquablation for benign prostatic hyperplasia.

Patients who underwent Aquablation between 2019 and 2024 across Asia, Europe, and North America were assessed to evaluate trends in treated prostate sizes, which were visualised using density plots. A corporate prospective database was maintained, incorporating case recordings and data collected by on-site company representatives. In addition, the incidence of postoperative bleeding-defined as transfusion or surgical takeback for haemostatic fulguration-was analysed using data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and procedure counts by the manufacturer.

A total of 70 270 Aquablation procedures were evaluated over the period from 2019 to 2024. The mean (standard deviation) prostate volume was 87.3 (42.4) mL, with a maximum recorded size of 1189 mL. Density plot analysis of prostate volumes demonstrated consistent utilisation of Aquablation across the full range of prostate sizes throughout all years studied. The overall rate of blood transfusion or return to the operating room for haemostatic fulguration was 0.2%, indicating a favourable safety profile across a very wide range of prostate sizes.

Aquablation has been consistently utilised across a broad spectrum of prostate sizes, with a low overall rate of transfusion or return to the operating room for bleeding control. These findings highlight the procedure's broad applicability and favourable safety profile in real-world practice from 2019 to 2024.