LOCALIZED HYPERTHERMIA VERSUS THE SHAM PROCEDURE IN OBSTRUCTIVE BENIGN HYPERPLASIA OF THE PROSTATE - A PROSPECTIVE RANDOMIZED STUDY

Hyperthermia was shown to cause improvement in 50 to 60% of the patients with benign prostatic hyperplasia (BPH) without considering placebo effects. We studied 68 patients randomly assigned to a treatment group (38) and a sham group (30) who underwent the same manipulation but without applying radio frequency power. The Biodan Prostathermer* was used. Criteria for inclusion were based on objective and subjective symptoms. Treatment was performed 6 times at 43 +/- 0.5C for the treatment group. Followup evaluation was performed at 3 months, and the same objective and subjective symptoms were recorded. We observed a statistically significant subjective improvement in the sham group (33%) that was not accompanied by any significant objective improvement. In the treatment group the subjective response was significantly better regarding number of patients (68%) and response rate, and was substantiated by a significant improvement in all objective symptoms (53% of the patients) except voided volume. Therefore, hyperthermia treatment had a definite therapeutic effect on BPH in excess of placebo.