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Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates
OBJECTIVE: To compare the outcomes of Aquablation in 30–80 mL prostates with those in 80–150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6972548/ https://www.ncbi.nlm.nih.gov/pubmed/31599044 http://dx.doi.org/10.1111/bju.14917 |
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author | Nguyen, David‐Dan Barber, Neil Bidair, Mo Gilling, Peter Anderson, Paul Zorn, Kevin C. Badlani, Gopal Humphreys, Mitch Kaplan, Steven Kaufman, Ronald So, Alan Paterson, Ryan Goldenberg, Larry Elterman, Dean Desai, Mihir Lingeman, Jim Roehrborn, Claus Bhojani, Naeem |
author_facet | Nguyen, David‐Dan Barber, Neil Bidair, Mo Gilling, Peter Anderson, Paul Zorn, Kevin C. Badlani, Gopal Humphreys, Mitch Kaplan, Steven Kaufman, Ronald So, Alan Paterson, Ryan Goldenberg, Larry Elterman, Dean Desai, Mihir Lingeman, Jim Roehrborn, Claus Bhojani, Naeem |
author_sort | Nguyen, David‐Dan |
collection | PubMed |
description | OBJECTIVE: To compare the outcomes of Aquablation in 30–80 mL prostates with those in 80–150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. PATIENTS AND METHODS: Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W‐I]; NCT02505919) is a prospective, double‐blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W‐II; NCT03123250) is a prospective, multicentre, single‐arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12‐month outcomes in 116 W‐I and 101 W‐II study patients. Students’ t‐test or Wilcoxon tests were used for continuous variables and Fisher’s test for binary variables. RESULTS: The mean (SD) operative time was 33 (17) and 37 (13) min in W‐I and W‐II, respectively. Actual treatment time was 4 and 8 min in W‐I and W‐II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W‐I and 17.1 in W‐II (P = 0.605). By 3 months, Clavien–Dindo grade ≥II events occurred in 19.8% of W‐I patients and 34.7% of W‐II patients (P = 0.468). CONCLUSION: Aquablation clinically normalises outcomes between patients with 30–80 mL prostates and patients with 80–150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long‐term outcomes of procedure durability are needed. |
format | Online Article Text |
id | pubmed-6972548 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-69725482020-01-27 Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates Nguyen, David‐Dan Barber, Neil Bidair, Mo Gilling, Peter Anderson, Paul Zorn, Kevin C. Badlani, Gopal Humphreys, Mitch Kaplan, Steven Kaufman, Ronald So, Alan Paterson, Ryan Goldenberg, Larry Elterman, Dean Desai, Mihir Lingeman, Jim Roehrborn, Claus Bhojani, Naeem BJU Int Robotics & Laparoscopy OBJECTIVE: To compare the outcomes of Aquablation in 30–80 mL prostates with those in 80–150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. PATIENTS AND METHODS: Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W‐I]; NCT02505919) is a prospective, double‐blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W‐II; NCT03123250) is a prospective, multicentre, single‐arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12‐month outcomes in 116 W‐I and 101 W‐II study patients. Students’ t‐test or Wilcoxon tests were used for continuous variables and Fisher’s test for binary variables. RESULTS: The mean (SD) operative time was 33 (17) and 37 (13) min in W‐I and W‐II, respectively. Actual treatment time was 4 and 8 min in W‐I and W‐II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W‐I and 17.1 in W‐II (P = 0.605). By 3 months, Clavien–Dindo grade ≥II events occurred in 19.8% of W‐I patients and 34.7% of W‐II patients (P = 0.468). CONCLUSION: Aquablation clinically normalises outcomes between patients with 30–80 mL prostates and patients with 80–150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long‐term outcomes of procedure durability are needed. John Wiley and Sons Inc. 2019-11-08 2020-01 /pmc/articles/PMC6972548/ /pubmed/31599044 http://dx.doi.org/10.1111/bju.14917 Text en © 2019 The Authors BJU International Published by John Wiley & Sons Ltd on behalf of BJU International. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Robotics & Laparoscopy Nguyen, David‐Dan Barber, Neil Bidair, Mo Gilling, Peter Anderson, Paul Zorn, Kevin C. Badlani, Gopal Humphreys, Mitch Kaplan, Steven Kaufman, Ronald So, Alan Paterson, Ryan Goldenberg, Larry Elterman, Dean Desai, Mihir Lingeman, Jim Roehrborn, Claus Bhojani, Naeem Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates |
title | Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates |
title_full | Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates |
title_fullStr | Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates |
title_full_unstemmed | Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates |
title_short | Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 mL prostates |
title_sort | waterjet ablation therapy for endoscopic resection of prostate tissue trial (water) vs water ii: comparing aquablation therapy for benign prostatic hyperplasia in 30–80 and 80–150 ml prostates |
topic | Robotics & Laparoscopy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6972548/ https://www.ncbi.nlm.nih.gov/pubmed/31599044 http://dx.doi.org/10.1111/bju.14917 |
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