A Systematic Review and Single-Arm Meta-Analysis on the Efficacy of High-Intensity, Focused Ultrasound for Benign Prostatic Hyperplasia Treatment: A Forgotten Option?

Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of prostate tissue, commonly affecting older men. This condition leads to lower urinary tract symptoms (LUTS), which significantly affect the quality of life. Over time, extensive research has been conducted regarding BPH treatment, exploring various treatment options. High-intensity focused ultrasound (HIFU) is a non-invasive treatment modality that has shown promise in initial studies. However, evidence regarding its long-term efficacy and safety remains inconclusive. This study evaluates HIFU's safety and efficacy for BPH treatment, identifying gaps for future research. The study conducted comprehensive searches across the PubMed, Google Scholar, Cochrane Central, and ClinicalTrials.gov databases, covering English-language articles from 1994 to 2023. Inclusion criteria focused on peer-reviewed studies, with more than 10 patients utilizing ultrasound image-guided HIFU for BPH while excluding other HIFU modalities lacking ultrasound image guidance. Data extraction targeted primary outcomes (peak flow rate, International Prostate Symptom Score (IPSS), postvoid residual volume) and secondary outcomes (treatment time, follow-up duration). Statistical analysis utilized a random effects model with heterogeneity assessed by I² statistics and the Q test, alongside subgroup analysis based on study design. The risk of bias assessment employed the Cochrane Collaboration tool for randomized controlled trials and the methodological index for nonrandomized studies. Among 560 identified articles, 12 studies with 522 patients met the inclusion criteria. Primary outcomes showed improvements in Qmax (1 month: 2.50 ml/s, 12 months: 6.22 ml/s) and IPSS (1 month: -9.37 points, 12 months: -11.60 points). Reported complications included transient hematuria, hematospermia, and urinary retention. HIFU presents significant clinical improvements in treating BPH, albeit with slow progression attributed to specific techniques and the ablative approach. Manageable complication profiles are observed, yet study design flaws hinder a comprehensive evaluation of HIFU efficacy. The authors suggest areas for clinical optimization, emphasizing the necessity of further research.