Comment on ‘Aquablation for benign prostatic hyperplasia: real‐world prostate size relevance and bleeding events across 6 years’

We read with interest the article by Bitar et al. [1] in the BJU International evaluating postoperative bleeding after Aquablation using post-market data from 70 270 procedures performed from 2019 to 2024 across Asia, Europe, and North America. The authors should be commended for assembling a large real-world experience and for focusing on clinically important bleeding outcomes. First, the study defines postoperative bleeding as transfusion or return to the operating room for haemostatic fulguration. While these are meaningful severe events, the manuscript does not specify the outcome assessment window, such as during the index admission or within 30 days. In BPH surgery, a substantial portion of bleeding burden is managed without transfusion or re-operation, including clot retention, prolonged catheter irrigation, emergency department visits, and re-admissions. Clarifying the time horizon and, if feasible, reporting additional bleeding-related outcomes would make the results easier to translate into patient counselling and perioperative planning. Second, several analytical details that directly affect the reported event rates are not described. The authors merged a corporate prospective case detail database with the United States Food and Drug Administration Manufacturer and User Facility Device Experience database (FDA MAUDE) and relied on manufacturer-reported procedure counts as denominators. The manuscript does not explain how duplicate reports were identified across sources, how multiple submissions related to a single clinical episode were handled, or how regional event capture aligns with regional denominators when presenting stratified rates. Providing transparent linkage and de-duplication rules, along with a sensitivity analysis using internal surveillance alone vs MAUDE alone, would help readers judge the robustness of the pooled incidence estimates. Finally, the discussion attributes the marked decline in transfusion and takeback rates over time to refinements in haemostasis and the standardisation of focal bladder neck cautery beginning in early 2020. Although plausible, the manuscript presents mainly descriptive annual rates without confidence intervals or formal trend testing. In addition, the title emphasises prostate size relevance, yet bleeding outcomes are not reported by prostate volume categories. We encourage the authors to add uncertainty measures, consider a before and after analysis around the 2020 protocol change, and report transfusion and takeback rates across clinically meaningful prostate size strata to better support the proposed interpretation. In conclusion, this large real-world analysis offers reassuring signals regarding severe bleeding events after Aquablation across a wide range of prostate sizes. Addressing the points above would further improve clarity, reproducibility, and clinical applicability. Shuo Lin: Supervision, writing – original draft, writing – review and editing. Jianjie Ju: Writing – original draft, investigation, writing – review and editing. The authors declare that they have no known competing financial interests or personal relationships that could have influenced the work reported in this paper.