Photoselective vaporization of the prostate for the treatment of benign prostatic hyperplasia: 12-month results from the first United States multicenter prospective trial

Purpose: We report the 1-year efficacy and safety of photoselective vaporization of the prostate (PVP) for symptomatic and obstructive benign prostatic hyperplasia (BPH). Materials and Methods: A prospective clinical trial was performed in 139 men clinically diagnosed with symptomatic bladder outlet obstruction secondary to BPH who were enrolled and treated with a high power, 80 W, quasicontinuous wave potassium-titanyl-phosphate laser at 6 American medical centers across the country. Efficacy parameters were mean and percent changes from baseline in the American Urological Association Symptom Index (AUA-SI) score, quality of life score QOL), peak urinary flow rate (Qmax), post-void residual urine volume (PVR) and transrectal ultrasound prostate volume measurement. Patients were evaluated 1, 3, 6 and 12 months following treatment. At each followup evaluation side effects were elicited. Results: Significant improvements in AUA-SI score, QOL score, Qmax and PVR were noted as early as 1 month after PVP treatment. At 12 months the mean AUA-SI score decreased from 23.9 to 4.3 (p < 0.0001) and the QOL score decreased from 4.3 to 1.1 (p < 0.0001), while mean Qmax increased from 7.8 to 22.6 ml per second (p < 0.0001). PVR decreased from 114.3 to 24.8 ml (p < 0.0001), while the transrectal ultrasound volume reduction went from 54.6 ml at baseline to 34.4 ml. There was no significant blood loss or fluid absorption during or immediately after PVP. Complications consisted of transient hematuria, dysuria and urinary retention in 12 (8.6%), 13 (9.3%) and 7 (5%) patients, respectively. Conclusions: PVP is a unique, safe and effective outpatient modality that provides immediate symptomatic and urodynamic relief of bladder outlet obstruction secondary to BPH. Long-term followup is needed to validate further the maintenance of clinical efficacy beyond 1 year.