To test the non‐inferiority of bipolar transurethral vaporization of the prostate (TUVP) compared to GreenLight laser (GL) photoselective vaporization of the prostate (PVP) for reduction of benign prostatic hyperplasia‐related lower urinary tract symptoms in a randomized trial.
Eligible patients with prostate volumes of 30–80 mL were randomly allocated to GL‐PVP (n = 58) or bipolar TUVP (n = 61). Non‐inferiority of symptom score (International Prostate Symptom Score [IPSS]) at 24 months was evaluated. All peri‐operative variables were recorded and compared. Urinary (IPSS, maximum urinary flow rate and post‐void residual urine volume) and sexual (International Index of Erectile Function‐15) outcome measures were evaluated at 1, 4, 12 and 24 months. Need for retreatment and complications, change in PSA level and health resources‐related costs of both procedures were recorded and compared.
Baseline and peri‐operative variables were similar in the two groups. At 1, 4, 12 and 24 months, 117, 116, 99 and 96 patients, respectively, were evaluable. Regarding urinary outcome measures, there was no significant difference between the groups. The mean ± sd IPSS at 1 and 2 years was 7.1 ± 3 and 7.9 ± 2.9 (P = 0.8), respectively, after GL‐PVP and 6.3 ± 3.1 and 7.2 ± 2.8, respectively, after bipolar TUVP (P = 0.31). At 24 months, the mean difference in IPSS was 0.7 (95% confidence interval −0.6 to 2.3; P = 0.6). The median (range) postoperative PSA reduction was 64.7 (25–99)% and 65.9 (50–99)% (P = 0.006) after GL‐PVP, and 32.1 (28.6–89.7)% and 39.3 (68.8–90.5)% (P = 0.005) after bipolar TUVP, at 1 and 2 years, respectively. After 2 years, retreatment for recurrent bladder outlet obstruction was reported in eight (13.8%) and 10 (16.4%) patients in the GL‐PVP and bipolar TUVP groups, respectively (P = 0.8). The mean estimated cost per bipolar TUVP procedure was significantly lower than per GL‐PVP procedure after 24 months (P = 0.01).
In terms of symptom control, bipolar TUVP was not inferior to GL‐PVP at 2 years. Durability of the outcome needs to be tracked. The greater cost of GL‐PVP compared with bipolar TUVP is an important concern.