Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic obstruction: 1-year clinical outcomes of a phase II study
Abstract
Objectives: To evaluate the safety and efficacy of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) as a minimally invasive alternative for benign prostatic obstruction (BPO).
Patients and methods: This prospective, single-centre, early phase II study (NCT03350529) included 30 men with BPO scheduled for primary transurethral resection of the prostate. Assessments over 12 months included uroflowmetry, prostate-specific antigen (PSA) levels, and validated questionnaires at baseline and 3-month intervals. MRI was performed at baseline and at 3 and 12 months. Medication use and adverse events (AEs) were recorded and graded using the Clavien-Dindo classification.
Results: The median patient age at treatment was 67 years. During the 12-month post-TULSA follow-up, prostate volume decreased from a median of 52 to 32 mL, and PSA levels from 3.1 to 1.5 μg/L. The maximum flow rate increased from 11.1 to 18.3 mL/s (P < 0.001), and the average flow rate from 4.2 to 9.1 mL/s (P < 0.001). Residual volume decreased from 71 to 40 mL, and voided volume increased from 211 to 301 mL. The International Prostate Symptom Score (IPSS) decreased from 17 to 4 (P < 0.001), and IPSS quality of life score improved from 4 to 1 (P < 0.001). The 26-item Expanded Prostate Cancer Index Composite urinary irritative/obstructive scores improved from 66 to 94 (P < 0.001), and urinary incontinence scores improved from 86 to 100 (P = 0.008). Sexual function remained stable or…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 30 participants or records.
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