WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation ® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia

No AccessJournal of UrologyAdult Urology1 May 2018WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia Peter Gilling, Neil Barber, Mohamed Bidair, Paul Anderson, Mark Sutton, Tev Aho, Eugene Kramolowsky, Andrew Thomas, Barrett Cowan, Ronald P. Kaufman, Andrew Trainer, Andrew Arther, Gopal Badlani, Mark Plante, Mihir Desai, Leo Doumanian, Alexis E. Te, Mark DeGuenther, and Claus Roehrborn Peter GillingPeter Gilling Tauranga Urology Research, Tauranga, New Zealand Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author , Neil BarberNeil Barber Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, United Kingdom More articles by this author , Mohamed BidairMohamed Bidair San Diego Clinical Trials, San Diego, California More articles by this author , Paul AndersonPaul Anderson Royal Melbourne Hospital, Melbourne, Australia Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author , Mark SuttonMark Sutton Houston Metro Urology, Houston, Texas More articles by this author , Tev AhoTev Aho Addenbrooke’s Hospital, Cambridge University Hospitals, Cambridge, United Kingdom More articles by this author , Eugene KramolowskyEugene Kramolowsky Virginia Urology, Richmond, Virginia More articles by this author , Andrew ThomasAndrew Thomas Princess of Wales Hospital, Bridgend, Wales, United Kingdom More articles by this author , Barrett CowanBarrett Cowan Urology Associates, P.C., Englewood, Colorado More articles by this author , Ronald P. KaufmanRonald P. Kaufman Albany Medical College, Albany, New York More articles by this author , Andrew TrainerAndrew Trainer Adult Pediatric Urology and Urogynecology, P.C., Omaha, Nebraska More articles by this author , Andrew ArtherAndrew Arther Adult Pediatric Urology and Urogynecology, P.C., Omaha, Nebraska More articles by this author , Gopal BadlaniGopal Badlani Wake Forest School of Medicine, Winston-Salem, North Carolina More articles by this author , Mark PlanteMark Plante University of Vermont Medical Center, Burlington, Vermont More articles by this author , Mihir DesaiMihir Desai Institute of Urology, University of Southern California, Los Angeles, California Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author , Leo DoumanianLeo Doumanian Institute of Urology, University of Southern California, Los Angeles, California More articles by this author , Alexis E. TeAlexis E. Te Weill Cornell Medical College, New York, New York Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author , Mark DeGuentherMark DeGuenther Urology Centers of Alabama, Birmingham, Alabama Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author , and Claus RoehrbornClaus Roehrborn Department of Urology, Southwestern Medical Center, University of Texas Southwestern, Dallas, Texas More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.12.065AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract 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. References 1 : Current medical therapies for men with lower urinary tract symptoms and benign prostatic hyperplasia: achievements and limitations. Rev Urol2008; 10: 14. Google Scholar 2 : The prevalence of prostatism: a population-based survey of urinary symptoms. J Urol1993; 150: 85. Link, Google Scholar 3 AUA Practice Guidelines Committee: AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: diagnosis and treatment recommendations. J Urol2003; 170: 530. Link, Google Scholar 4 : Is transurethral resection of the prostate still justified?. BJU Int1999; 83: 227. Google Scholar 5 : Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol2011; 185: 1793. Link, Google Scholar 6 : Treatment options for benign prostatic hyperplasia in older men. Med Sci Monit2008; 14: RA94. Google Scholar 7 : Complications of transurethral resection of the prostate (TURP)—incidence, management, and prevention. Eur Urol2006; 50: 969. Google Scholar 8 : Safety and tolerability of treatment for BPH. Eur Urol2006; 5: 1004. Google Scholar 9 : 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European multicentre randomised trial—the GOLIATH study. Eur Urol2014; 65: 931. Google Scholar 10 : Resection of the liver with a water jet. Br J Surg1982; 69: 93. Google Scholar 11 : Hepatic resection using a water jet dissector. HPB Surg1993; 6: 189. Google Scholar 12 : Waterjet hydrodissection: first experiences and short-term outcomes of a novel approach to bladder tumor resection. World J Urol2011; 29: 423. Google Scholar 13 : Aquablation—image-guided robot-assisted waterjet ablation of the prostate: initial clinical experience. BJU Int2016; 117: 923. Google Scholar 14 : Aquablation of the prostate for symptomatic benign prostatic hyperplasia: one-year results. J Urol2017; 197: 1565. Link, Google Scholar 15 : The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol1992; 148: 1549. Link, Google Scholar 16 : How I do it: balloon tamponade of prostatic fossa following Aquablation. Can J Urol2017; 24: 8937. Google Scholar 17 : Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg2004; 240: 205. Google Scholar 18 : Comparative analysis of two rates. Stat Med1985; 4: 213. Google Scholar 19 : Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol2011; 60: 1010. Google Scholar 20 : Male Sexual Health Questionnaire (MSHQ): scale development and psychometric validation. Urology2004; 64: 777. Google Scholar 21 : Validation of a severity index in female urinary incontinence and its implementation in an epidemiological survey. J Epidemiol Community Health1993; 47: 497. Google Scholar 22 : EuroQol—a new facility for the measurement of health-related quality of life. Health Policy1990; 16: 199. Google Scholar 23 : The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics1993; 4: 353. Google Scholar 24 : Holmium laser enucleation versus transurethral resection in patients with benign prostate hyperplasia: an updated systematic review with meta-analysis and trial sequential analysis. PLoS One2014; 9: e101615. Google Scholar 25 : Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol2015; 195: 1529. Google Scholar 26 : Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol2017; 24: 8802. Google Scholar 27 : Microwave thermotherapy for benign prostatic hyperplasia with the Dornier Urowave: results of a randomized, double-blind, multicenter, sham-controlled trial. Urology1998; 51: 19. Google Scholar 28 : Transurethral microwave thermotherapy for benign prostatic hyperplasia. Int Braz J Urol2003; 29: 251. Google Scholar 29 : Efficacy and safety of initial combination treatment of an alpha blocker with an anticholinergic medication in benign prostatic hyperplasia patients with lower urinary tract symptoms: updated meta-analysis. PLoS One2017; 12: e0169248. Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byKaplan S (2020) Re: Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 mL): 6-Month Results from the WATER II TrialJournal of Urology, VOL. 204, NO. 4, (853-853), Online publication date: 1-Oct-2020.Kaplan S (2020) Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate: Subgroup Analysis from a Blinded Randomized TrialJournal of Urology, VOL. 204, NO. 2, (358-359), Online publication date: 1-Aug-2020.Kaplan S (2019) Re: Do Patients Have to Choose between Ejaculation and Miction? A Systematic Review about Ejaculation Preservation Technics for Benign Prostatic Obstruction Surgical TreatmentJournal of Urology, VOL. 203, NO. 2, (226-226), Online publication date: 1-Feb-2020.Kaplan S (2019) Re: Aquablation versus Transurethral Resection of the Prostate: 1 Year United States–Cohort OutcomesJournal of Urology, VOL. 202, NO. 6, (1072-1074), Online publication date: 1-Dec-2019.Foster H, Dahm P, Kohler T, Lerner L, Parsons J, Wilt T and McVary K (2019) Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2019Journal of Urology, VOL. 202, NO. 3, (592-598), Online publication date: 1-Sep-2019.Cadeddu J (2019) Re: WATER II (80-150 ml) Procedural OutcomesJournal of Urology, VOL. 202, NO. 1, (12-12), Online publication date: 1-Jul-2019. Volume 199Issue 5May 2018Page: 1252-1261Supplementary Materials Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.Keywordsrobotic surgical proceduresprostatic hyperplasialower urinary tract symptomstransurethral resection of prostatewaterAcknowledgmentsWATER blinded investigators: Andre Abreu, James Armitage, Martin Bastuba, Stephanie Bolte, Simon Bott, Charles Bugg, Bilal Chughtai, Niall Corcoran, Euclid deSouza, Patrick Dougherty, Robert Evans, James Fagelson, Emily Fisher, April Hansen, Graham Hirst, Brad Hornberger, Catriona MacRae, Rajnesh Nirula, Kent Rollins, Nikhil Sapre, Gillian Stearns, Rob Sykrme, Charles Wakefield, Charles Welliver and Omid Yassaie.MetricsAuthor Information Peter Gilling Tauranga Urology Research, Tauranga, New Zealand Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author Neil Barber Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, United Kingdom More articles by this author Mohamed Bidair San Diego Clinical Trials, San Diego, California More articles by this author Paul Anderson Royal Melbourne Hospital, Melbourne, Australia Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author Mark Sutton Houston Metro Urology, Houston, Texas More articles by this author Tev Aho Addenbrooke’s Hospital, Cambridge University Hospitals, Cambridge, United Kingdom More articles by this author Eugene Kramolowsky Virginia Urology, Richmond, Virginia More articles by this author Andrew Thomas Princess of Wales Hospital, Bridgend, Wales, United Kingdom More articles by this author Barrett Cowan Urology Associates, P.C., Englewood, Colorado More articles by this author Ronald P. Kaufman Albany Medical College, Albany, New York More articles by this author Andrew Trainer Adult Pediatric Urology and Urogynecology, P.C., Omaha, Nebraska More articles by this author Andrew Arther Adult Pediatric Urology and Urogynecology, P.C., Omaha, Nebraska More articles by this author Gopal Badlani Wake Forest School of Medicine, Winston-Salem, North Carolina More articles by this author Mark Plante University of Vermont Medical Center, Burlington, Vermont More articles by this author Mihir Desai Institute of Urology, University of Southern California, Los Angeles, California Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author Leo Doumanian Institute of Urology, University of Southern California, Los Angeles, California More articles by this author Alexis E. Te Weill Cornell Medical College, New York, New York Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author Mark DeGuenther Urology Centers of Alabama, Birmingham, Alabama Financial interest and/or other relationship with PROCEPT BioRobotics. More articles by this author Claus Roehrborn Department of Urology, Southwestern Medical Center, University of Texas Southwestern, Dallas, Texas More articles by this author Expand All Advertisement PDF downloadLoading ...