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 effic acy and safety of transurethral needle ablation (TUNA(R)) in patients presenting in acute urinary retention due to benign prostatic hyperpla sia (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 tempera tures 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 wa s reestablished in a mean of 2.6 days. Three patients required TURF fo r persistent retention, and 2 patients had delayed TURF for bothersome symptoms. Two voiders died later of unrelated causes. Five patients w ere 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 volum e at baseline was 65.8 cc and decreased to 56 cc at 12 months (p = 0.1 11). The treatment was well tolerated by all patients, and side effect s were mild, including urinary tract infection and epididymo-orchitis. This study demonstrates the safety and effectiveness of TUNA(R) proce dure in patients with urinary retention due to benign prostatic hypert rophy. (C) 1996 Wiley-Liss, Inc.