A total of 220 patients with clinical benign prostatic hyperplasia (BPH), an AUA symptom index (AUA SI) of >13 points, and a peak flow rate of <12ml/s were randomly assigned to either active or sham treatment. All treatments were conducted as an outpatient procedure without general anesthesia. Shamtreated patients underwent a simulated 60-min treatment with an indwelling treatment catheter. Patients were followed at 1 week and at 1, 3, and 6 months. The treatments were well tolerated. The AUA SI dropped from 23.6 to 12.6 points at 6 months (P < 0.05) in the active group and from 23.9 to 17.9 points in the shamtreated group (P < 0.05 for the difference between groups). There was a significant difference between the groups at 6 months (P < 0.001). Similar and statistically significant changes occurred regarding the AUA bother index and the quality of life scores. Statistically significant improvements were also noted for the peak flow rate (from 7.7 to 10.6 ml/s at 6 months for the active group and from 8.1 to 9.6 ml/s for the shamtreated group; P < 0.05 for the difference between groups) and for the average flow rate. An improvement in the AUA SI of >30% was achieved by 72% versus 40% (active versus sham) and an improvement of >50% was accomplished by 48% versus 21% of the respective patients. Actively treated patients reported more dysuria, urgency, and ejaculatory dysfunction following treatment than did sham-treated patients. Urinary retention occurred in 5.4% of patients. The Dornier Urowave is better in improving symptoms, bother, quality of life, and flow rates than is a sham treatment in patients with symptomatic BPH. The treatments can be given on an outpatient basis with local anesthesia. Adverse events are in general transient and mild in nature. This device compares favorably with other second-generation devices. Extended follow-up is necessary to document the long-term durability of these improvements.
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