Objectives. To study the efficacy and safety of a new transurethral microwave thermotherapy device (the Urowave) in the treatment of men with clinical benign prostatic hyperplasia (BPH) in a randomized, double-blind, sham-controlled trial. Methods. A total of 220 patients (mean age 66.2 years) with clinical BPH, an American Urological Association symptom 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 under local anesthesia, with oral sedation and analgesia only. Patients were followed up at 1 week and 1, 3, and 6 months after treatment. Results. The treatments were well tolerated, and no patient received general 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). Statistically 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 sham treatment, P <0.05, between-group difference) and for average flow rate. 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-treated 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 (eg, hematospermia) was more common in actively treated patients as well. Secondary urinary retention after removal of the catheter occurred in 8 patients (5.4%). Conclusions. The Dornier Urowave transurethral microwave thermotherapy device for treatment of clinical BPH is effective in decreasing symptoms and bother and improving 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.
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