OBJECTIVES: To evaluate and compare the safety and effectiveness of two noncontact laser regimens for the treatment of human benign prostatic hyperplasia (BPH), and to assess the impact of the spatial distribution of the laser-induced lesions on treatment outcome. METHODS: This was a prospective, double-blind, randomized study that included 29 patients with BPH (both the patients and the study physician assistant in charge of the follow-up evaluation were blinded to the treatment rendered). 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 measured at the fiber tip). There were two study phases for each treatment group: the irradiated sites were not overlapping during the first phase (lesions 1.5 cm apart), and were overlapping during the second phase (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 urinary flow rate, and the postvoid residual in both treatment groups. These improvements were not statistically significantly different regardless of time or the phase of the study for the two treatment groups. There were 3 treatment failures, 2 of whom were later successfully re-treated with larger amounts of laser energy. Furthermore, the peak flows in the second phase of the study were statistically significantly higher than those in the first phase of the study, regardless of the treatment group. CONCLUSIONS: Our results suggest that both the 15 W for 180 s and the 50 W for 60 s are equally safe and effective treatments for BPH. Perhaps more importantly, they also suggest that the spatial distribution of lesions and overlapping of treated (irradiated) sites has significant impact on treatment outcome.
RCT Entities:
OBJECTIVES: To evaluate and compare the safety and effectiveness of two noncontact laser regimens for the treatment of humanbenign prostatic hyperplasia (BPH), and to assess the impact of the spatial distribution of the laser-induced lesions on treatment outcome. METHODS: This was a prospective, double-blind, randomized study that included 29 patients with BPH (both the patients and the study physician assistant in charge of the follow-up evaluation were blinded to the treatment rendered). 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 measured at the fiber tip). There were two study phases for each treatment group: the irradiated sites were not overlapping during the first phase (lesions 1.5 cm apart), and were overlapping during the second phase (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 urinary flow rate, and the postvoid residual in both treatment groups. These improvements were not statistically significantly different regardless of time or the phase of the study for the two treatment groups. There were 3 treatment failures, 2 of whom were later successfully re-treated with larger amounts of laser energy. Furthermore, the peak flows in the second phase of the study were statistically significantly higher than those in the first phase of the study, regardless of the treatment group. CONCLUSIONS: Our results suggest that both the 15 W for 180 s and the 50 W for 60 s are equally safe and effective treatments for BPH. Perhaps more importantly, they also suggest that the spatial distribution of lesions and overlapping of treated (irradiated) sites has significant impact on treatment outcome.