MICROWAVE THERMOTHERAPY FOR BENIGN PROSTATIC HYPERPLASIA WITH THE DORNIER UROWAVE - RESULTS OF A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, SHAM-CONTROLLED TRIAL

Objectives. To study the efficacy and safety of a new transurethral mi crowave thermotherapy device (the Urowave) in the treatment of men wit h clinical benign prostatic hyperplasia (BPH) in a randomized, double- blind, sham-controlled trial. Methods. A total of 220 patients (mean a ge 66.2 years) with clinical BPH, an American Urological Association s ymptom index (AUA SI) of 13 points or more, and a peak flow rate of 12 mL/s or less were enrolled and randomized 2:1 for active versus sham treatment. All treatments were conducted as an outpatient procedure un der local anesthesia, with oral sedation and analgesia only. Patients were followed up at 1 week and 1, 3, and 6 months after treatment. Res ults. The treatments were well tolerated, and no patient received gene ral or spinal anesthesia. The AUA SI dropped from 23.6 to 12.7 points at 6 months (P<0.05) in the active group and from 23.9 to 18.0 points in the sham-treated group (P<0.05, between-group difference). Statisti cally significant improvements were also noted for peak flow rate (7.7 to 10.7 mL/s at 6 months for active treatment, 8.1 to 9.8 mL/s for sh am treatment, P<0.05, between-group difference) and for average flow r ate. A decrease in AUA SI of more than 30% was achieved in 72% versus 38% of patients (active versus sham treatment, respectively) and more than 50% in 50% versus 19% of patients. In general, active Urowave-tre ated patients perceived ''a lot'' of improvement, whereas sham-treated patients perceived ''a little'' to ''some'' improvement. More of the actively treated patients had dysuria and urgency after treatment, and ejaculatory dysfunction leg, hematospermia) was more common in active ly treated patients as well. Secondary urinary retention after removal of the catheter occurred in 8 patients (5.4%). Conclusions. The Dorni er Urowave transurethral microwave thermotherapy device for treatment of clinical BPH is effective in decreasing symptoms and bother and imp roving quality of life and flow rate and is superior to sham treatment . Patients perceive a great deal of improvement, independent of their baseline symptom severity. Adverse events are in general transient and mild in nature. Extended follow-up is necessary to document long-term durability of improvements. (C) 1998, Elsevier Science Inc. All right s reserved.