The safety and efficacy of drug-coated balloon dilation system (Keeway) for benign prostate hyperplasia: a preclinical study.

PURPOSE: In recent years, minimally invasive procedures for benign prostatic hyperplasia (BPH) and urethral strictures have attracted great attention. There is an urgent need for studies investigating the safety and efficacy of the drug-coated balloon (DCB) dilation system (Keeway) for BPH. METHODS: The balloon was coated with paclitaxel (PTX). 21 male Labrador dogs were lastly randomized into the single-dose group (n = 12), double-dose group (n = 3), sham procedure group (n = 3), and blank control group (n = 3). The study period was 90 days. Blood and urine samples were collected before the procedure, and blood, urine, target tissues (prostate and bladder neck), and major organs (heart, liver, spleen, lung, kidney, and brain) were harvested at follow-up time points for subsequent processing and analysis. RESULTS: No significant PTX accumulation was observed in any specimen, and no pathological changes were detected in major organs, suggesting the safety of this approach. At 90 days, dilatation of the prostatic urethra was evident in both treatment and sham groups. CONCLUSION: This study suggested the safety and efficacy of the DCB dilation system (Keeway), encouraging further clinical investigation as a potential minimally invasive therapy for BPH, especially in Chinese population.