TRANSURETHRAL MICROWAVE THERMOTHERAPY V SHAM TREATMENT - DOUBLE-BLINDRANDOMIZED STUDY

Transurethral microwave thermotherapy (TUMT) is a single-session, 1-ho ur office-based treatment for benign prostatic hyperplasia, A randomiz ed, double-blind study has been conducted at our institutions involvin g 115 patients who, after satisfying the entry criteria, were randomiz ed in a 2:1 fashion to receive TUMT or a sham treatment, Three months' unblinding revealed both statistically and clinically significant imp rovement in the efficacy measures for the real treatment compared with the sham, The mean Madsen Symptom Score decreased 55% and the mean pe ak 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 patie nts improved in mean AUA Symptom Score by 43% v 26% for sham-treated p atients (P < 0.01), Reclassification of patients after therapy showed a greater shift to the mild category of AUA Symptom Score: 37% for TUM T patients v 6.5% for sham-treated patients, In addition, prostate-spe cific antigen elevation to > 4 times baseline was noted 1 week after T UMT v no statistically significant change for sham-treated patients, T his double-blind study demonstrates that thermotherapy's efficacy is n ot placebo related and that the mechanism of action is related to ther mal ablation of transition zone adenoma.