WATER: 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, Claus Roehrborn

Research output: Contribution to journalArticle

46 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1252-1261
Number of pages10
JournalJournal of Urology
Volume199
Issue number5
DOIs
StatePublished - May 1 2018

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Transurethral Resection of Prostate
Prostatic Hyperplasia
Randomized Controlled Trials
Safety
Prostate
Lower Urinary Tract Symptoms
Operative Time

Keywords

  • lower urinary tract symptoms
  • prostatic hyperplasia
  • robotic surgical procedures
  • transurethral resection of prostate
  • water

ASJC Scopus subject areas

  • Urology

Cite this

WATER : A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. / Gilling, Peter; Barber, Neil; Bidair, Mohamed; Anderson, Paul; Sutton, Mark; Aho, Tev; Kramolowsky, Eugene; Thomas, Andrew; Cowan, Barrett; Kaufman, Ronald P.; Trainer, Andrew; Arther, Andrew; Badlani, Gopal; Plante, Mark; Desai, Mihir; Doumanian, Leo; Te, Alexis E.; DeGuenther, Mark; Roehrborn, Claus.

In: Journal of Urology, Vol. 199, No. 5, 01.05.2018, p. 1252-1261.

Research output: Contribution to journalArticle

Gilling, P, Barber, N, Bidair, M, Anderson, P, Sutton, M, Aho, T, Kramolowsky, E, Thomas, A, Cowan, B, Kaufman, RP, Trainer, A, Arther, A, Badlani, G, Plante, M, Desai, M, Doumanian, L, Te, AE, DeGuenther, M & Roehrborn, C 2018, 'WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia', Journal of Urology, vol. 199, no. 5, pp. 1252-1261. https://doi.org/10.1016/j.juro.2017.12.065
Gilling, Peter ; Barber, Neil ; Bidair, Mohamed ; Anderson, Paul ; Sutton, Mark ; Aho, Tev ; Kramolowsky, Eugene ; Thomas, Andrew ; Cowan, Barrett ; Kaufman, Ronald P. ; Trainer, Andrew ; Arther, Andrew ; Badlani, Gopal ; Plante, Mark ; Desai, Mihir ; Doumanian, Leo ; Te, Alexis E. ; DeGuenther, Mark ; Roehrborn, Claus. / WATER : A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. In: Journal of Urology. 2018 ; Vol. 199, No. 5. pp. 1252-1261.
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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.",
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AU - Sutton, Mark

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AU - Thomas, Andrew

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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.

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