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 pati ent quality of life (QOL) of a novel transurethral microwave thermoabl ation 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 Urolo gix Targis thermoablation system on an outpatient basis, without gener al or regional anesthesia. Symptoms, flow rates, and QOL scores were d etermined before the study procedure and periodically thereafter up to 6 months. Results. Mean American Urological Association (AUA) score i n the microwave group diminished 50% (P < 0.0005) by the 6-month evalu ation (10.5, 95% confidence interval [CI] 9.2 to 11.8) compared with b aseline values (20.8, 95% CI 19.8 to 21.9). The sham group also exhibi ted lower postprocedural AUA scores; however, the magnitude of the pos tprocedural decline in AUA score in the microwave group was significan tly 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 i n symptoms was similar among patients with initially moderate versus i nitially severe symptoms. Mean peak urinary flow rate (Qmax) in the mi crowave 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 sign ificantly 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 resul ted in a significantly greater (P < 0.05) positive impact on patient Q OL than did the sham procedure. By 6 months, the QOL score in microwav e-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 gr eater durability of treatment effects was also evident with microwave than with sham treatment, as judged by the higher proportion of microw ave-treated patients (98.4%) requiring no further treatment during the 6-month study period versus 83.3% of sham control patients (P < 0.000 5). Microwave treatment was well tolerated, and complications were gen erally minor, readily manageable, and transitory. Conclusions. The mic rowave thermoablation system proved to be an effective and safe treatm ent modality for BPH, with a positive impact on patient QOL. (C) 1998, Elsevier Science Inc. All rights reserved.