Localized Hyperthermia Versus the Sham Procedure in Obstructive Benign Hyperplasia of the Prostate: A Prospective Randomized Study

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Abstract
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.