A high-efficiency microwave thermoablation system for the treatment of benign prostatic hyperplasia: Results of a randomized, sham-controlled, prospective, double-blind, multicenter clinical trial

Objectives. To determine the effectiveness, safety, and impact on patient quality of life (QOL) of a novel transurethral microwave thermoablation system for the treatment of benign prostatic hyperplasia (BPH). Methods. A total of 169 patients with BPH were randomized to undergo a 1-hour microwave (n = 125) or sham (n = 44) procedure using the Urologix Targis thermoablation system on an outpatient basis, without general or regional anesthesia. Symptoms, flow rates, and QOL scores were determined before the study procedure and periodically thereafter up to 6 months. Results. Mean American Urological Association (AUA) score in the microwave group diminished 50% (P < 0.0005) by the 6-month evaluation (10.5, 95% confidence interval [CI] 9.2 to 11.8) compared with baseline values (20.8, 95% CI 19.8 to 21.9). The sham group also exhibited lower postprocedural AUA scores; however, the magnitude of the postprocedural decline in AUA score in the microwave group was significantly greater (P < 0.01) than that in the sham group. Half the microwave group had an AUA score of less than 9 by 6 months, and the decrease in symptoms was similar among patients with initially moderate versus initially severe symptoms. Mean peak urinary flow rate (Qmax) in the microwave group increased 51% (P < 0.0005) by 6 months to 11.8 mL/s (95% CI 10.7 to 13.0) versus a pretreatment value of 7.8 mL/s (95% CI 7.4 to 8.2). The magnitude of the postprocedural increase in Qmax was significantly greater in the microwave than the sham group (P < 0.05). In nearly half the microwave group (47%), Qmax increased 50% or more by 6 months compared with 24% of the sham group. Microwave treatment resulted in a significantly greater (P < 0.05) positive impact on patient QOL than did the sham procedure. By 6 months, the QOL score in microwave-treated patients (2.2, 95% Cl 1.9 to 2.4) averaged 48% lower (P < 0.0005) than that at baseline (4.2, 95% CI 4.0 to 4.4). Significantly greater durability of treatment effects was also evident with microwave than with sham treatment, as judged by the higher proportion of microwave-treated patients (98.4%) requiring no further treatment during the 6-month study period versus 83.3% of sham control patients (P < 0.0005). Microwave treatment was well tolerated, and complications were generally minor, readily manageable, and transitory. Conclusions. The microwave thermoablation system proved to be an effective and safe treatment modality for BPH, with a positive impact on patient QOL. (C) 1998, Elsevier Science Inc. All rights reserved.