12-Month Clinical Outcomes of MRI-Guided Transurethral Ultrasound Ablation (TULSA) for Benign Prostatic Hyperplasia (BPH)

MRI-guided transurethral ultrasound ablation (TULSA) presents an effective therapeutic option for patients suffering from benign prostatic hyperplasia (BPH). This study reports the 12-month clinical outcomes for 30 men who underwent TULSA as part of a phase 1-2 clinical trial (NCT03350529). The enrolled participants, who experienced lower urinary tract symptoms (LUTS) due to BPH and were initially scheduled for primary transurethral resection of the prostate (TURP), underwent a thorough evaluation before and after the procedure. Quality of life (QoL) questionnaires, including the EPIC-26, International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIEF-5), were administered at various intervals: baseline, and then at 3, 6, 9, 12, 18, 24, and 36 months post-TULSA. Additionally, prostate-specific antigen (PSA) levels were recorded, and MRI scans were conducted at baseline, 3 months, and 12 months post-procedure. The results indicated significant improvements across multiple parameters. At baseline, the median age of the participants was 67 years, with a median PSA level of 3.1 µg/l and an average prostate volume of 51.5 ml. Following TULSA, there were noteworthy reductions in prostate volume, which decreased from 51.5 ml to 31 ml, and PSA levels dropped from 3.1 µg/l to 1.5 µg/l. Additionally, there were significant improvements in urinary flow rates and post-void residual volumes, which reflected enhanced functional status. The IPSS score improved significantly from 16.5 to 4, highlighting a substantial reduction in urinary symptoms and an enhancement in the overall quality of life for the participants. With only minimal adverse events reported, TULSA has emerged as a safe and effective treatment option for BPH, demonstrating sustained symptom relief and marked improvements in the quality of life for patients over the 12-month follow-up period.