WATER II (80–150 mL) procedural outcomes

Mihir Desai, Mo Bidair, Naeem Bhojani, 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, Mitchell R HumphreysClaus Roehrborn, Steven Kaplan, Jay Motola, Kevin C. Zorn

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objectives: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). Methods: Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80–150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. Results: The mean (range) prostate volume was 107 (80–150) mL. The mean (range) operating time was 37 (15–97) min and aquablation resection time was 8 (3–15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien–Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. Conclusions: Aquablation is feasible and safe in treating men with men with large prostates (80–150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).

Original languageEnglish (US)
Pages (from-to)106-112
Number of pages7
JournalBJU International
Volume123
Issue number1
DOIs
StatePublished - Jan 1 2019

Fingerprint

Prostate
Prostatic Hyperplasia
Hemostasis
Electrocoagulation
Traction
Adenoma
Multicenter Studies
Length of Stay
Urinary Bladder
Hospitalization
Catheters
Demography
Clinical Trials
Databases
Prospective Studies
Hemorrhage
Safety
Therapeutics

Keywords

  • aquablation
  • benign prostatic hyperplasia
  • large prostates
  • robotics

ASJC Scopus subject areas

  • Urology

Cite this

Desai, M., Bidair, M., Bhojani, N., Trainer, A., Arther, A., Kramolowsky, E., ... Zorn, K. C. (2019). WATER II (80–150 mL) procedural outcomes. BJU International, 123(1), 106-112. https://doi.org/10.1111/bju.14360

WATER II (80–150 mL) procedural outcomes. / Desai, Mihir; Bidair, Mo; Bhojani, Naeem; 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, Mitchell R; Roehrborn, Claus; Kaplan, Steven; Motola, Jay; Zorn, Kevin C.

In: BJU International, Vol. 123, No. 1, 01.01.2019, p. 106-112.

Research output: Contribution to journalArticle

Desai, M, Bidair, M, Bhojani, N, 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, MR, Roehrborn, C, Kaplan, S, Motola, J & Zorn, KC 2019, 'WATER II (80–150 mL) procedural outcomes', BJU International, vol. 123, no. 1, pp. 106-112. https://doi.org/10.1111/bju.14360
Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E et al. WATER II (80–150 mL) procedural outcomes. BJU International. 2019 Jan 1;123(1):106-112. https://doi.org/10.1111/bju.14360
Desai, Mihir ; Bidair, Mo ; Bhojani, Naeem ; 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, Mitchell R ; Roehrborn, Claus ; Kaplan, Steven ; Motola, Jay ; Zorn, Kevin C. / WATER II (80–150 mL) procedural outcomes. In: BJU International. 2019 ; Vol. 123, No. 1. pp. 106-112.
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AU - Desai, Mihir

AU - Bidair, Mo

AU - Bhojani, Naeem

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, Mitchell R

AU - Roehrborn, Claus

AU - Kaplan, Steven

AU - Motola, Jay

AU - Zorn, Kevin C.

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N2 - Objectives: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). Methods: Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80–150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. Results: The mean (range) prostate volume was 107 (80–150) mL. The mean (range) operating time was 37 (15–97) min and aquablation resection time was 8 (3–15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien–Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. Conclusions: Aquablation is feasible and safe in treating men with men with large prostates (80–150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).

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