A NOVEL TRANSURETHRAL MICROWAVE THERMAL ABLATION SYSTEM TO TREAT BENIGN PROSTATIC HYPERPLASIA - RESULTS OF A PROSPECTIVE MULTICENTER CLINICAL-TRIAL

Purpose: We evaluated the efficacy, safety and impact on quality of li fe of a newly designed microwave thermal ablation system in patients w ith benign prostatic hyperplasia (BPH). Materials and Methods: Microwa ve thermal ablation was administered to 154 BPH patients at 3 centers in Canada and the United Kingdom during a single 1 to 2-hour office or clinic procedure without general or regional anesthesia and without n eed for potent medications necessitating intensive patient monitoring. Various measures of symptoms, voiding function and patient; quality o f life were assessed at baseline, 6 weeks, and 3, 6, 9 and 12 months a fter treatment. Results: Mean American Urological Association symptom score 12 months after treatment (8.8, 95% confidence interval 7.7 to 1 0.0) was significantly lower (p < 0.05) by 56% than that at baseline ( 20.1, 95% confidence interval 19.1 to 21.0). The incidence of mild sym ptoms increased from 0 to 57%, while that of severe symptoms decreased from 49 to 8%. There was a significant increase (p < 0.05) in peak fl ow rate of 45% from 9.3 ml. per second (95% confidence interval 8.8 to 9.7) at baseline to 13.4 ml. per second (95% confidence interval 12.5 to 14.4) at 12 months. Similar symptomatic and urodynamic improvement s occurred in all prostate volume categories. Convalescence was rapid after treatment with little or no need for home bed rest or restrictio n of usual activities. Patients expressed a high level of satisfaction with treatment and found the prostate symptoms to be significantly mo re tolerable. Adverse events were infrequent, transient and readily ma naged. Conclusions: Microwave thermal ablation proved to be safe and e ffective for treatment of BPH with a significant positive impact on pa tient quality of life.