RANDOMIZED CLINICAL-TRIAL COMPARING LOW POWER-SLOW HEATING VERSUS HIGH POWER-RAPID HEATING NONCONTACT NEODYMIUM-YTTRIUM-ALUMINUM-GARNET LASER REGIMENS FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

Objectives. To evaluate and compare the safety and effectiveness of tw o noncontact laser regimens for the treatment of human benign prostati c hyperplasia (BPH), and to assess the impact of the spatial distribut ion of the laser-induced lesions on treatment outcome. Methods. This w as a prospective, double-blind, randomized study that included 29 pati ents with BPH (both the patients and the study physician assistant in charge of the follow-up evaluation were blinded to the treatment rende red). The patients were randomized to receive either a 15 W for 180 s (15 patients) or 50 W for 60 s (14 patients) laser regimen (powers mea sured at the fiber tip). There were two study phases for each treatmen t group: the irradiated sites were not overlapping during the first ph ase (lesions 1.5 cm apart), and were overlapping during the second pha se (lesion less than 1.0 cm apart). Results. Morbidity was minimal in both groups. At 1 year of follow-up, there was Significant improvement of the American Urological Association-7 symptom score, the peak urin ary flow rate, and the postvoid residual in both treatment groups. The se improvements were not statistically significantly different regardl ess of time or the phase of the study for the two treatment groups. Th ere were 3 treatment failures, 2 of whom were later successfully re-tr eated with larger amounts of laser energy. Furthermore, the peak flows in the second phase of the study were statistically significantly hig her than those in the first phase of the study, regardless of the trea tment group. Conclusions. Our results suggest that both the 15 W for 1 80 s and the 50 W for 60 s are equally safe and effective treatments f or BPH. Perhaps more importantly, they also suggest that the spatial d istribution of lesions and overlapping of treated (irradiated) sites h as significant impact on treatment outcome.