Objective: To evaluate the clinical and endoscopic effects of transrectal focal ultrasound (Sonablate) on benign prostatic hypertrophy.
Method: This was a phase II study, performed in 13 patients with benign prostatic hypertrophy. Patients were evaluated before treatment, and 45 days and 90 days after treatment by means of a symptom score (1-PSS), uroflowmetry, estimation of prostatic volume by transrectal ultrasonography, and urethroprostatic endoscopy. A transducer with a focal length of 3.5 cm was used in 12 patients. One patient was treated with a transducer with a focal length of 3 cm. We used an acoustic energy level at the focal point of 1,680 W/cm2 for the last two patients.
Results: With a follow-up of 3 months, the symptom score was only moderately improved (decreasing from 20 +/- 7 to 14 +/- 9, p < 0.03), with no improvement of uroflowmetry and tissue destruction was not demonstrated on endoscopy in any of the patients.
Conclusion: The therapeutic applications of focal ultrasound thermotherapy are potentially very vast, but, up until now, have only rarely exceeded the experimental stage. Our data emphasize that future developments are essential before this technology can be included in therapeutic alternatives for benign prostatic hypertrophy.