Presenting Author:	Thomas A. Gardner
Presentation Type:	Paper
Category:		7 Surgical Therapy and New Technology
Keywords:	High Intensity Focused Ultrasound, BPH, Thermal Ablation, Safety


HIGH INTENSITY FOCUSED ULTRASOUND FOR THE TREATMENT 
OF BPH: INTERIM RESULTS OF PHASE III PMA STUDY.


Michael O. Koch and Thomas A. Gardner, Indianapolis, Indiana; Martin Resnick and 
Alan Seftel, Cleveland, Ohio; Ivan Grunberger, Brooklyn, New York; Christopher Steidle, Fort Wayne, Indiana; 
James Cochran, Dallas, Texas.  (Presentation by Dr. Gardner)
Introduction: Five university medical hospitals and private clinics treated patients with symptomatic benign 
prostatic hyperplasia (BPH) using the Sonablate 200TM (Focus Surgery, Inc. Indianapolis, IN) to ablate the 
obstructive tissue with high intensity focused ultrasound (HIFU) and relieve the symptoms resulting from this 
condition.  The objective of this study is to demonstrate that HIFU can safely and effectively ablate 
prostate tissue with minimal complications and result in significant symptomatic relief of BPH symptoms and 
improvement in peak urinary flow.
Methods:  60 patients from the ages 50 to 80 were treated, with an average prostate size of 38.4gms, on an 
outpatient basis with HIFU at five sites.  20 patients were treated under IV sedation protocol and the 
remainder under general anesthesia.  A Foley catheter was inserted into the bladder via the urethra and was 
kept in-situ during the treatment. The catheter aided in proper positioning of the probe and also helped to 
enhance the effect of ultrasound beam on the targeted tissue.  Immediately after the HIFU therapy the 
catheter was replaced with a new Foley catheter.  The patients returned home within a few hours after the 
procedure. The Foley’s catheter was placed electively to avoid any incidence of acute urinary retention 
following the therapy. The catheter was removed after 4-5 days. A cooling device was used to ensure lower 
temperature at the intervening rectal wall tissue. Average treatment time was 38 minutes. 
Results: All of the patients were treated safely without pain, significant blood loss or major 
complications.  No discomfort or clinical differences were observed between those patients treated under 
general compared with those under IV sedation.  Normal rectal wall temperature was maintained throughout the 
procedures.  Average Qmax scores improved from 8.7ml/sec to 11.7ml/sec for a 34% improvement at one year 
(Pre: N=59, one-year: N=25).  Average AUA Symptom Scores improved from 22.8 to 8.4 for a 63% improvement at 
one year (Pre: N=58, One Year N=28).  Minor complications include hemataspermia (28%), hematuria (23%), 
transient retention (10%), transient incontinence (5%), and UTI (2%), long-term dysuria (0%), impotence (0%)



Conclusion: HIFU therapy is safe and effective for providing symptomatic relief of BPH symptoms and the 
treatment can be performed as an outpatient procedure. There ware no significant long-term side effects.