A study of the efficacy and safety of transurethral needle ablation (TUNA(R)) treatment for benign prostatic hyperplasia

The objective of this early phase III study was to determine the efficacy and safety of transurethral needle ablation (TUNA(R)) in patients presenting in acute urinary retention due to benign prostatic hyperplasia (BPH). Between September 1993 and August 1994, 20 patients of mean age 68.8 years were entered into a two-center study and treated with TUNA(R) after presenting in acute urinary retention and having failed at least one trial of voiding. A mean of 5.4 lesions at shield temperatures of 54.6 degrees C were produced. Patients were reviewed at 1, 3, 6, and 12 months (mean, 6.2 months). In 17 of 20 patients, voiding was reestablished in a mean of 2.6 days. Three patients required TURF for persistent retention, and 2 patients had delayed TURF for bothersome symptoms. Two voiders died later of unrelated causes. Five patients were lost to follow-up at 6 months but were voiding when last reviewed. Symptom scores decreased from a mean of 19.0 (range 4 - 35) to 8.25 (range 1 - 20) at 12 months (p = 0.06). Mean peak flow rate was 11.4 ml/sec (range 6.6 - 16.8) at 12 months (p = 0.001). Mean prostatic volume at baseline was 65.8 cc and decreased to 56 cc at 12 months (p = 0.111). The treatment was well tolerated by all patients, and side effects were mild, including urinary tract infection and epididymo-orchitis. This study demonstrates the safety and effectiveness of TUNA(R) procedure in patients with urinary retention due to benign prostatic hypertrophy. (C) 1996 Wiley-Liss, Inc.