Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL)

6-month results from the WATER II trial

Mihir Desai, Mo Bidair, Kevin C. Zorn, Andrew Trainer, Andrew Arther, Eugene Kramolowsky, Leo Doumanian, Dean Elterman, Ronald P. Kaufman, James Lingeman, Amy Krambeck, Gregg Eure, Gopal Badlani, Mark Plante, Edward Uchio, Greg Gin, Larry Goldenberg, Ryan Paterson, Alan So, Mitch Humphreys & 4 others Claus Roehrborn, Steven Kaplan, Jay Motola, Naeem Bhojani

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. Methods: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. Results: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien–Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. Conclusions: Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time.

Original languageEnglish (US)
JournalBJU International
DOIs
StatePublished - Jan 1 2019

Fingerprint

Prostatic Hyperplasia
Prostate
Length of Stay
Safety
Lower Urinary Tract Symptoms
Residual Volume
Patient Discharge
Prostate-Specific Antigen
Multicenter Studies
Canada
Urine
Prospective Studies
Hemorrhage

Keywords

  • #UroBPH
  • aquablation
  • BPH
  • LUTS
  • prostate surgery
  • robotics
  • urology

ASJC Scopus subject areas

  • Urology

Cite this

Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL) : 6-month results from the WATER II trial. / Desai, Mihir; Bidair, Mo; Zorn, Kevin C.; Trainer, Andrew; Arther, Andrew; Kramolowsky, Eugene; Doumanian, Leo; Elterman, Dean; Kaufman, Ronald P.; Lingeman, James; Krambeck, Amy; Eure, Gregg; Badlani, Gopal; Plante, Mark; Uchio, Edward; Gin, Greg; Goldenberg, Larry; Paterson, Ryan; So, Alan; Humphreys, Mitch; Roehrborn, Claus; Kaplan, Steven; Motola, Jay; Bhojani, Naeem.

In: BJU International, 01.01.2019.

Research output: Contribution to journalArticle

Desai, M, Bidair, M, Zorn, KC, Trainer, A, Arther, A, Kramolowsky, E, Doumanian, L, Elterman, D, Kaufman, RP, Lingeman, J, Krambeck, A, Eure, G, Badlani, G, Plante, M, Uchio, E, Gin, G, Goldenberg, L, Paterson, R, So, A, Humphreys, M, Roehrborn, C, Kaplan, S, Motola, J & Bhojani, N 2019, 'Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL): 6-month results from the WATER II trial', BJU International. https://doi.org/10.1111/bju.14703
Desai, Mihir ; Bidair, Mo ; Zorn, Kevin C. ; Trainer, Andrew ; Arther, Andrew ; Kramolowsky, Eugene ; Doumanian, Leo ; Elterman, Dean ; Kaufman, Ronald P. ; Lingeman, James ; Krambeck, Amy ; Eure, Gregg ; Badlani, Gopal ; Plante, Mark ; Uchio, Edward ; Gin, Greg ; Goldenberg, Larry ; Paterson, Ryan ; So, Alan ; Humphreys, Mitch ; Roehrborn, Claus ; Kaplan, Steven ; Motola, Jay ; Bhojani, Naeem. / Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL) : 6-month results from the WATER II trial. In: BJU International. 2019.
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abstract = "Objective: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. Methods: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. Results: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5{\%} of men, which met the study design goal of < 65{\%} (P < 0.001). At 6 months, 22{\%} of the patients had experienced a Clavien–Dindo grade 2, 14{\%} a grade 3 and 5{\%} a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44{\%} reduction. Conclusions: Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time.",
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author = "Mihir Desai and Mo Bidair and Zorn, {Kevin C.} and Andrew Trainer and Andrew Arther and Eugene Kramolowsky and Leo Doumanian and Dean Elterman and Kaufman, {Ronald P.} and James Lingeman and Amy Krambeck and Gregg Eure and Gopal Badlani and Mark Plante and Edward Uchio and Greg Gin and Larry Goldenberg and Ryan Paterson and Alan So and Mitch Humphreys and Claus Roehrborn and Steven Kaplan and Jay Motola and Naeem Bhojani",
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T1 - Aquablation for benign prostatic hyperplasia in large prostates (80–150 mL)

T2 - 6-month results from the WATER II trial

AU - Desai, Mihir

AU - Bidair, Mo

AU - Zorn, Kevin C.

AU - Trainer, Andrew

AU - Arther, Andrew

AU - Kramolowsky, Eugene

AU - Doumanian, Leo

AU - Elterman, Dean

AU - Kaufman, Ronald P.

AU - Lingeman, James

AU - Krambeck, Amy

AU - Eure, Gregg

AU - Badlani, Gopal

AU - Plante, Mark

AU - Uchio, Edward

AU - Gin, Greg

AU - Goldenberg, Larry

AU - Paterson, Ryan

AU - So, Alan

AU - Humphreys, Mitch

AU - Roehrborn, Claus

AU - Kaplan, Steven

AU - Motola, Jay

AU - Bhojani, Naeem

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objective: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. Methods: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. Results: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien–Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. Conclusions: Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time.

AB - Objective: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. Methods: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. Results: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien–Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien–Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. Conclusions: Aquablation is safe and effective in treating men with larger prostates (80–150 mL), without significant increase in procedure or resection time.

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KW - aquablation

KW - BPH

KW - LUTS

KW - prostate surgery

KW - robotics

KW - urology

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