Ahmed M Elshal1, Mohamed A Elkoushy2, Ahmed R El-Nahas3, Ahmed M Shoma3, Adel Nabeeh3, Serge Carrier4, Mostafa M Elhilali5. 1. Urology Division, McGill University, Montreal, Canada; Mansoura Urology and Nephrology Center, Mansoura, Egypt. 2. Urology Division, McGill University, Montreal, Canada; Department of Urology, Suez Canal University, Ismailia, Egypt. 3. Mansoura Urology and Nephrology Center, Mansoura, Egypt. 4. Urology Division, McGill University, Montreal, Canada. 5. Urology Division, McGill University, Montreal, Canada. Electronic address: mostafa.elhilali@muhc.mcgill.ca.
Abstract
PURPOSE: After the advent of the GreenLight XPS™ (180 W) 532 nm laser, photoselective vapo-enucleation of the prostate could compete with holmium laser enucleation of the prostate as a size independent procedure. We assessed whether photoselective vapo-enucleation of the prostate-XPS is not less effective than holmium laser enucleation of prostate for improvement of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: A randomized controlled noninferiority trial comparing holmium laser enucleation of the prostate to photoselective vapo-enucleation of the prostate-XPS 180 W was conducted. I-PSS, flow rate, residual urine, prostate specific antigen and prostate volume changes as well as perioperative and late adverse events were compared. Noninferiority of I-PSS at 1 year was evaluated using a 1-sided test at 5% level of significance. The statistical significance of other comparators was assessed at the (2-sided) 5% level. RESULTS:Overall 50 and 53 patients were included in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups, respectively. Operative time, hospital stay and time to catheter removal were comparable between the groups. There was significant, comparable improvement in I-PSS and post-void residual urine volume at 1, 4 and 12 months. After 4 months prostate size reduction was significantly higher in the holmium laser enucleation of prostate group (74.3% vs 43.1%, p=0.001). At 12 months maximum urine flow rate was significantly higher in the holmium laser enucleation of prostate group (26.4 ±11.5 vs 18.4 ±7.5 ml per second, p=0.03). Re-intervention was needed in 2 and 3 cases in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups, respectively (p=1.0). Mean estimated cost per holmium laser enucleation of prostate procedure was significantly lower than per photoselective vapo-enucleation of the prostate procedure. CONCLUSIONS: Compared to holmium laser enucleation of prostate, GreenLight XPS laser photoselective vapo-enucleation of the prostate is safe, noninferior and effective in treatment of benign prostatic hyperplasia.
RCT Entities:
PURPOSE: After the advent of the GreenLight XPS™ (180 W) 532 nm laser, photoselective vapo-enucleation of the prostate could compete with holmium laser enucleation of the prostate as a size independent procedure. We assessed whether photoselective vapo-enucleation of the prostate-XPS is not less effective than holmium laser enucleation of prostate for improvement of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: A randomized controlled noninferiority trial comparing holmium laser enucleation of the prostate to photoselective vapo-enucleation of the prostate-XPS 180 W was conducted. I-PSS, flow rate, residual urine, prostate specific antigen and prostate volume changes as well as perioperative and late adverse events were compared. Noninferiority of I-PSS at 1 year was evaluated using a 1-sided test at 5% level of significance. The statistical significance of other comparators was assessed at the (2-sided) 5% level. RESULTS: Overall 50 and 53 patients were included in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups, respectively. Operative time, hospital stay and time to catheter removal were comparable between the groups. There was significant, comparable improvement in I-PSS and post-void residual urine volume at 1, 4 and 12 months. After 4 months prostate size reduction was significantly higher in the holmium laser enucleation of prostate group (74.3% vs 43.1%, p=0.001). At 12 months maximum urine flow rate was significantly higher in the holmium laser enucleation of prostate group (26.4 ±11.5 vs 18.4 ±7.5 ml per second, p=0.03). Re-intervention was needed in 2 and 3 cases in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups, respectively (p=1.0). Mean estimated cost per holmium laser enucleation of prostate procedure was significantly lower than per photoselective vapo-enucleation of the prostate procedure. CONCLUSIONS: Compared to holmium laser enucleation of prostate, GreenLight XPS laser photoselective vapo-enucleation of the prostate is safe, noninferior and effective in treatment of benign prostatic hyperplasia.
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