Tolerability of high energy transurethral microwave thermotherapy with topical urethral anesthesia:: Results of a prospective, randomized, single-blinded clinical trial

Purpose: We determine the tolerability of high energy transurethral microwave thermotherapy with topical urethral anesthesia alone without supplementary systemic sedoanalgesia. Materials and Methods: A total of 45 patients with symptomatic benign prostatic hyperplasia were randomized to high energy transurethral microwave thermotherapy using either topical urethral anesthesia alone (topical anesthesia group) or topical anesthesia with adjunctive intravenous sedoanalgesia (sedoanalgesia group). Pain was evaluated sequentially by means of a 0 to 10 visual analog scale score. Posttreatment followup included determinations of International Prostate Symptom Score, peak flow rate, post-void residual urine, and quality of life score at 6 and 12 weeks. Results: Upon commencement of microwave treatment mean visual analog scale score was 1.3 (95% confidence interval [CI], 1.0 to 1.7) in the sedoanalgesia group and 1.4 (95% CI, 1.0 to 1.9) in the topical anesthesia group. During therapy visual analog scale score increased to a peak at 30 minutes of 2.0 (95% CI, 1.6 to 2.4) and 2.2 (95% CI, 1.7 to 2.6) in the sedoanalgesia and topical anesthesia groups, respectively. Thereafter, visual analog scale score continuously declined, falling to 0.1 (95% CI, 0.0 to 0.2) and 0.2 (95% CI, 0.0 to 0.3) in the 2 respective groups by 1 hour following conclusion of the treatment period. There was no statistically significant difference between the groups in the treatment profile of visual analog scale scores (p = 0.701). Significant posttreatment improvements were demonstrated in International Prostate Symptom Score, peak flow rate, post-void residual urine and quality of life scores but there were no significant differences between the groups in the magnitude of improvement in these outcome measures. Conclusions: High energy transurethral microwave thermotherapy is well tolerated by patients under topical anesthesia alone and, therefore, can be administered in the outpatient setting without potent medications that necessitate intensive patient monitoring pose risks for side effects and add to treatment costs.