TY - JOUR
T1 - WATER
T2 - A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia
AU - Gilling, Peter
AU - Barber, Neil
AU - Bidair, Mohamed
AU - Anderson, Paul
AU - Sutton, Mark
AU - Aho, Tev
AU - Kramolowsky, Eugene
AU - Thomas, Andrew
AU - Cowan, Barrett
AU - Kaufman, Ronald P.
AU - Trainer, Andrew
AU - Arther, Andrew
AU - Badlani, Gopal
AU - Plante, Mark
AU - Desai, Mihir
AU - Doumanian, Leo
AU - Te, Alexis E.
AU - DeGuenther, Mark
AU - Roehrborn, Claus
PY - 2018/5
Y1 - 2018/5
N2 - Purpose: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Materials and Methods: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. Results: Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). Conclusions: Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.
AB - Purpose: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Materials and Methods: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. Results: Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). Conclusions: Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.
KW - lower urinary tract symptoms
KW - prostatic hyperplasia
KW - robotic surgical procedures
KW - transurethral resection of prostate
KW - water
UR - http://www.scopus.com/inward/record.url?scp=85044360002&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85044360002&partnerID=8YFLogxK
U2 - 10.1016/j.juro.2017.12.065
DO - 10.1016/j.juro.2017.12.065
M3 - Article
C2 - 29360529
AN - SCOPUS:85044360002
VL - 199
SP - 1252
EP - 1261
JO - Journal of Urology
JF - Journal of Urology
SN - 0022-5347
IS - 5
ER -