Prospective multicenter ProLase II clinical trial of neodymium:yttrium-aluminum-garnet laser prostatectomy.

摘要

OBJECTIVES: To assess the clinical efficacy of neodymium:yttrium-aluminum-garnet (YAG) laser coagulation prostatectomy using a broad-angle, divergent-beam, side-firing fiber. METHODS: Eighty adult men with voiding symptoms caused by benign prostatic hyperplasia were enrolled in a prospective multicenter study of free-beam neodymium:YAG laser prostatectomy performed with the ProLase II side-firing delivery fiber. Voiding outcomes were assessed at 3, 6, and 12 months postoperatively. RESULTS: At 1-year follow-up, peak urinary flow rates were increased by 105%, postvoid residual urine volumes had decreased by 38%, and the AUA symptom index had decreased by 60%. Serious treatment-related complications occurred in 3 of 80 patients (3.8%). The reoperation rate through 1-year follow-up was 2.7%. CONCLUSIONS: Neodymium:YAG laser prostatectomy performed with the ProLase II delivery fiber has proven safe and efficacious with durable results through 1 year in the relief of symptomatic bladder outlet obstruction due to benign prostatic hyperplasia.