Transurethral microwave thermotherapy v sham treatment: double-blind randomized study

Transurethral microwave thermotherapy (TUMT) is a single-session, 1-hour office-based treatment for benign prostatic hyperplasia. A randomized, double-blind study has been conducted at our institutions involving 115 patients who, after satisfying the entry criteria, were randomized in a 2:1 fashion to receive TUMT or a sham treatment. Three months' unblinding revealed both statistically and clinically significant improvement in the efficacy measures for the real treatment compared with the sham. The mean Madsen Symptom Score decreased 55% and the mean peak flow rate increased 58% in the TUMT-treated patients v 28% and 27% in the sham-treated patients (P < 0.001). Also, the TUMT-treated patients improved in mean AUA Symptom Score by 43% v 26% for sham-treated patients (P < 0.01). Reclassification of patients after therapy showed a greater shift to the mild category of AUA Symptom Score: 37% for TUMT patients v 6.5% for sham-treated patients. In addition, prostate-specific antigen elevation to >4 times baseline was noted 1 week after TUMT v no statistically significant change for sham-treated patients. This double-blind study demonstrates that thermotherapy's efficacy is not placebo related and that the mechanism of action is related to thermal ablation of transition zone adenoma.