Objective: The aim of this study was to determine the long-term outcome after transrectal high-intensity focused ultrasound (HIFU) therapy for patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Methods: Between June 1992 and March 1995, 98 men (mean age: 66 years) with LUTS due to BPH underwent transrectal HIFU therapy at our institution, and the data of 80 patients were included in this long-term analysis. Principal inclusion criteria were a peak flow rate (Qmax) < or =15 ml/s, AUA/IPSS score > or =18 and a prostate volume < or =75 ml. Postoperatively, patients were seen at 6-month intervals with assessment of symptom score, uroflowmetry and post-void residual volume. In the present analysis, follow-up was terminated at 4 years. The mean follow-up of the study population (excluding the patients who underwent transurethral resection of the prostate, TURP, due to insufficient therapeutic response) was 41.3 months (range: 13-48 months).
Results: In treatment responders (HIFU only; n = 45), the symptom score decreased from preoperatively 19.6 to 8.5 (-53%) after 12 months and subsequently showed only marginal fluctuations within the 4-year study period. The Qmax increased from preoperatively 9.1 to 11.8 ml/s (+30%) after 12 months and gradually declined to 10.2 ml/s (+12%) after 4 years. 35 men (43.8%) underwent TURP due to insufficient therapeutic response during the 4-year study period. The mean time interval between HIFU therapy and TURP was 26.5+/-2.7 months (range: 1-48 months). The retreatment-free period was significantly longer for patients with a pretreatment average flow rate >5 ml/s (p = 0.05) and lower grades of urodynamically documented bladder outflow obstruction (p = 0.03). A similar trend, which did not reach statistical significance, was noted for individuals with higher Qmax and lower post-void residuals.
Conclusions: These long-time data indicate that transrectal HIFU therapy for BPH, at least in its present form, did not stand the test of time, as 43.8% of patients had to undergo TURP within 4 years after initial therapy. These data underline the need for long-term studies with follow-ups over several years to reliably assess the role of less invasive treatment options for BPH.