Quality of life assessment in patients treated with lower energy thermotherapy (Prostasoft 2.0): results of a randomized transurethral microwave thermotherapy versus sham study.

PURPOSE We evaluated the impact of lower energy transurethral microwave thermotherapy on quality of life and quality of sexual function in patients with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS A total of 50 patients with BPH were randomized to receive either lower energy transurethral microwave thermotherapy treatment (Prostasoft 2.0) or placebo treatment and followed for 26 weeks after treatment. All patients completed a Madsen symptom score and quality of life questionnaire to assess acceptability, daily activities, psychological well-being, social activities and improvement in quality of life. A sexual function questionnaire was used to assess changes in sexual function after microwave thermotherapy. RESULTS A significant difference in voiding parameters and symptom score was found between the transurethral microwave thermotherapy and sham groups. Maximum uroflow changed from 9.6 ml. per second at baseline to 13.9 ml. per second and from 9.9 ml. per second at baseline to 9.6 ml. per second at 26 weeks for transurethral microwave thermotherapy and sham groups, respectively. Madsen score improved from 13.2 to 5.3 for the transurethral microwave thermotherapy group and from 11.9 to 9.1 for the sham group. For quality of life measures, a statistically significant difference in favor of the transurethral microwave thermotherapy group was found only for the acceptability item. At baseline and after 26 weeks no statistically significant difference was observed between the 2 groups for Quality of Life measures documenting sexual function. However, almost 20% of patients treated by either transurethral microwave thermotherapy or sham claimed at 26 weeks after treatment that treatment had influenced sexual function. CONCLUSIONS Although significant changes in objective and subjective parameters were found in patients after lower energy microwave thermotherapy, the change in quality of life was minimal. In addition to the minimal invasiveness of transurethral microwave thermotherapy, preservation of sexual function is appealing.