Long-term results of a prospective, randomized clinical trial comparing tuna® to turp for the tretament of symptomatic bph

INTRODUCTION AND OBJECTIVES: The TUNA® Procedure is an FDA-approved, minimally invasive treatment for men with symptomatic BPH. To further evaluate the TUNA® Procedure, a prospective, randomized clinical trial comparing TUNA® with TURP was performed. METHODS: From 11/94 to 7/95,56 men were treated with TURP and 65 men were treated with TUNA®. The mean age of men treated was 66±5.8 years, with prostate volumes ranging from 16-75 cc (mean: 36±4.8 cc). RESULTS: Pre 1 month 6 month 12 month Peak Flow rate parameter n parameter n p value parameter n pvalue parameter n p value TURP 8.9 56 20.5 52 <.0001 20.6 47 <.0001 21 38 <.0001 TUNA 8.9 85 13.2 60 <.0001 13.5 50 <.0001 14.6 53 <.0001 Pre 1month 6 month 12 month AUA Symp. Score parameter n parameter n p value parameter n p value parameter n p value TURP 24.1 56 11.8 53 <.0001 8 47 <.0001 7.9 41 <.0001 TUNA 23.9 65 12.2 58 <.0001 10.8 60 <.0001 11.7 57 <.0001 Pre 1 montti 6 month 12 month Quality of Life parameter n parameter n p value parameter n p value parameter n p value TURP 12.8 58 7.5 52 <.0001 3.3 46 <.0001 3.8 41 <.0001 TUNA 11.8 65 5.2 59 <.0001 4.2 61 <.0001 4.3 56 <.0001 Pre 1 month 6 month 12 month Postvoid Residual parameter n parameter n p value parameter n p value parameter n p value TURP 81.9 58 49.6 52 0.0112 46.9 46 0.0044 46.8 38 0.0085 TUNA 99.5 65 65.6 52 0.0559 70.8 52 0.2071 Adverse events Study conort Erective dysfunction Retrogradeahacykatuib Urinary incontience Urinary Postproc. catherization TURP 6.20% 29.60% 3.70% 11.10% 100% TUNA 0.00% 0.00% 0.00% 3.10% 38.50% CONCLUSIONS: TUNA® and TURP are equally effective in improving AUA Symptom and Bother scores, but TUNA® provides a more rapid improvement in Quality of Life Score. TURP, however, is more effective in improving peak urinary flow rate and postvoid residual urine volume, but is associated with greater side effects. These data demonstrate that the TUNA® Procedure is a safe and effective alternative to TURP, and that results are durable through 12 months of follow-up.