Objective: To establish clinical efficacy and safety of High Intensity Focused Ultrasound (HIFU) for the treatment of benign prostatic hyperplasia (BPH) in a multiple site clinical study.
Methods: Seven clinical sites were set up for the studies, five in the USA, one in Canada and one in Japan respectively. Sixty two patients were enrolled in these three studies. Transrectal ultrasound probes made to produce sufficient acoustic power required for focused ultrasound surgery of the prostate as well as to perform imaging of the prostate, were employed in the study. The probes ware made of 2.5, 3.0, 3.5, 4.0 and 4.5 cm focal length transducers to treat varying prostate sizes and shapes and operated at 4 MHz frequency for both imaging and treatment. The employed ultrasound device produced both transverse and longitudinal images of the prostate on the same display. The images were used for selection of tissue volume, treatment planning and monitoring of tissue during the HIFU treatment cycle. The patients in the USA and Canada were followed for two years and those in Japan were followed for one year on a regular interval. The results were evaluated for changes in the peak flow rate (Qmax in ml/s), quality of life (QOL) and International Prostate Symptom Score (IPSS).
Results: The average pre / post treatment results at 180 days were significantly different for Qmax, QOL and IPSS 8.5/14.2 (ml/s), 4.7/2.1 and 22/10 respectively.
Conclusion: Under this protocol, HIFU was found safe and efficacious for the treatment of BPH. The HIFU treatment produced statistically significant results for the parameters measured with least complications. Additionally, the HIFU treatment was found to be durable.