A randomized, blinded study comparing microwave thermotherapy (dornier urowave(tm)) with a sham procedure in patients with clinical benign prostatic hyperplasia (bph)

INTRODUCTION AND OBJECTIVES: Microwave thermotherapy has been identified as an effective treatment for patients with clinical BPH. We report the results of a multi-center, prospective, randomized, sham-controlled, singleblinded trial with blinding of the follow-up investigator, using a second generation transurethral microwave thermotherapy machine (Dornier Urowave(tm)). METHODS: A total of 205 patients were randomized at a ratio of 2:1 (active versus sham) and treated in five centers. Patients had to have an AUA Symptom Index of >12 points and a peak flow rate of < 12 ml/sec with a voided volume of > 125 ml. AUA SI was (he primary outcome parameter, and peak flow rates, BPH Impact Index and Quality of Life (QOL) scores secondary outcome parameter RESULTS: Active and Sham groups were well randomized at baseline. Age ranged from 54 to 82 (mean 66.1) years, prostate volume by TRUS from 25 to 99 (mean 48.1) ml. The following table shows a pairwise analysis of the outcome parameters for active and sham treated patients. AUA SI BPH II QOL Qmax (0 to 35) (0 to 13) (0 to 6) (ml/sec) Act Sham Act Sham Act Sham Act Sham Baseline 237 23.8 7.1 73 43 43 7.7 81 6 Month 12.117.5 23 43 21 29 96 No significant changes were noted regarding prostate volume. PSA values increased significantly in the active group and then returned to near baseline values at 6 months follow-up. 25 adverse events occurred of which hematuria and bladder spasms were the most common. Retention following removal of the catheter occurred in 18% of patients. CONCLUSIONS: Treatment with the Dormer Urowave™ is safe, provides excellent symptom, bother and quality of life improvements, and improvement in peak flow rate superior to sham treatment.