Office-Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia Under Local Anesthesia: 2-Year Results from a Dose Range Confirmatory Trial

To evaluate the safety and tolerability profile of transperineal laser ablation (TPLA) for patients with benign prostatic hyperplasia in an office setting under sedative-free anesthesia, including the functional outcome results at 24 months. This is a prospective, single-center, dose range confirmatory trial involving 20 male patients. TPLA was performed by urologists in an office setting, using nonsedative local anesthesia. Self-administered nitrous oxide/oxygen dissociating gas was optional. Tolerability was assessed using a visual analog scale. Safety was evaluated by recording Grade 3 or worse adverse events within 30 days after the procedure. International Prostate Symptom Score, Sexual Health Inventory for Men, ejaculation function, and uroflowmetry parameters were assessed at 6, 12, and 24 months. All 20 procedures were performed as intended without request of cessation from any patient, who tolerated them very well, recording a median pain score of 2 (range 1-4). It is important to note that there was a rapid escalation of dose, and the last 18 consecutive patients were initiated at the maximal energy dose of 7 watts. No hospital transfers were recorded, and no urgent hospital admissions within 30 days post-procedure occurred. There was 1 Grade 3 complication registered during the 24-month study interval. We observed a statistically significant and sustained reduction in the median International Prostate Symptom Score at 6 months (6, 3-8), 12 months (3, 5-2), and 24 months (3, 2-4) when compared with baseline values (14, 12-17). Uroflowmetry parameters showed a similar trend. The median Sexual Health Inventory for Men values did not change significantly, and only approximately 10% of patients reported absence of anterograde ejaculation at 12 and 24 months. TPLA for benign prostatic hyperplasia is a safe and well-tolerated office-based procedure, with durable benefits on functional outcomes over 2 years of follow-up. Further studies are required to confirm these results. NCT04760483.