Transurethral microwave thermotherapy versus sham treatment: early report of a randomized double-blind study

ABSTRACT

Transurethral microwave thermotherapy [TUMT] for the management of clinical BPH has recently been introduced and investigated in a number of centres. A prospective double-blind randomized study was designed to evaluate the extent of any placebo response. The inclusion criteria were a total Madsen score > 8, a Qmax urine from 100 ml to 200 ml. Thirty-three patients were studied; of these, 15 underwent randomization to the sham treatment and 18 to thermotherapy. The patients were unblinded at 3 months. The patients in the placebo arm that did not improve were offered treatment on an open label. We report our results after a follow-up of 3 months. The thermotherapy group showed a 40% increase in the mean flow rate [from 6.78 to 9.49 ml/sec], P = .0099, a 38% decrease in the mean total symptoms core [from 14.44 to 9.35], P = .0008, and a decrease of 5% in the mean residual urine [from 135.8 to 129.2 mls], P = .842. The sham group showed a 21% increase in the mean flow rate [from 6.96 to 8.45 ml/sec], P = .5044, a 33% decrease in the mean total symptom score [from 13.66 to 9.18], p = .005, and a decrease of 2% in the mean postvoid residual urine volume [from 141.5 to 138.2 mls], P = .9022. There was a 16% incidence of acute urinary retention in the treated group. Statistical analysis comparing the TUMT and sham group parameters at baseline and 3 months after the treatment showed no significant difference. We conclude that there is a significant subjective improvement in the sham group which should always be taken into consideration. The objective and subjective improvements in the thermotherapy group suggest that this treatment modality could be an alternative to surgical treatment of benign prostatic hyperplasia