The safety and effectiveness of tissue ablation by coagulative necrosi
s with high-intensity focused ultrasound (HIFU) applied through a rect
al probe to 36 patients with symptomatic benign prostatic hyperplasia
(BPH) was investigated in a phase II clinical trial. Overall, HIFU tre
atment was well-tolerated, the. mean hospital stay being 1.1 days. Neg
ative side effects were transient urinary retention in 32/36 patients,
hematuria in 2 patients and hematospermia resolving after 3-4 weeks (
n = 15). After 3 months the maximum flow rate/s (Q(max)) increased fro
m 9.0 +/- 3.9 to 14.4 +/- 7.0 ml/s, the median flow rate/s (Q(M90)) fr
om 4.9 +/- 2.4 to 7.6 +/- 4.17 ml/s; the postvoid residual volume decr
eased from 128 +/- 88 to 57 +/- 35 ml and the AUA symptom score from 2
5.5 +/- 5 to 13.2 +/- 4.4. In conclusion, it was shown that tissue abl
ation in patients with symptomatic BPH using HIFU is safe and dramatic
ally reduces both obstructive and irritative symptoms and leads to a s
ignificant increase in uroflow and a decrease in postvoid residual vol
ume.