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: W e evaluated the impact of lower energy transurethral microwave thermotherapy on quality of life and quality of sexual function in patients w ith benign prostatic hyperplasia (B PH ). M aterials 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. A ll 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 thermo­ therapy 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. A t 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 thermo­ therapy or sham claimed at 26 weeks after treatment that treatment had influenced sexual