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 mi crowave thermotherapy with topical urethral anesthesia alone without s upplementary systemic sedoanalgesia. Materials and Methods: A total of 45 patients with symptomatic benign prostatic hyperplasia were random ized to high energy transurethral microwave thermotherapy using either topical urethral anesthesia alone (topical anesthesia group) or topic al 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 residu al urine, and quality of life score at 6 and 12 weeks. Results: Upon c ommencement of microwave treatment mean visual analog scale score was 1.3 (95% confidence interval [CI], 1.0 to 1.7) in the sedoanalgesia gr oup and 1.4 (95% CI, 1.0 to 1.9) in the topical anesthesia group. Duri ng 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 sedoa nalgesia and topical anesthesia groups, respectively. Thereafter, visu al 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 stat istically significant difference between the groups in the treatment p rofile of visual analog scale scores (p = 0.701). Significant posttrea tment improvements were demonstrated in International Prostate Symptom Score, peak flow rate, post-void residual urine and quality of life s cores but there were no significant differences between the groups in the magnitude of improvement in these outcome measures. Conclusions: H igh energy transurethral microwave thermotherapy is well tolerated by patients under topical anesthesia alone and, therefore, can be adminis tered in the outpatient setting without potent medications that necess itate intensive patient monitoring pose risks for side effects and add to treatment costs.