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, Mitch Humphreys, Claus Roehrborn, Steven Kaplan, Jay Motola, Kevin C Zorn

Journal: BJU international 2019;123(1):106-112

PMID: 29694702

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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).

Address: Institute of Urology, University of Southern California, Los Angeles, CA, USA.; San Diego Clinical Trials, San Diego, CA, USA.; University of Montreal Hospital Centre, University of Montréal, Montreal, QC, Canada.; Adult Paediatric Urology and Urogynecology, P.C., Omaha, NE, USA.; Virginia Urology, Richmond, VA, USA.; University Health Network University of Toronto, Toronto, ON, Canada.; Albany Medical College, Albany, NY, USA.; Indiana University Health Physicians, Indianapolis, IN, USA.; Urology of Virginia, Virginia Beach, VA, USA.; Wake Forest School of Medicine, Winston-Salem, NC, USA.; University of Vermont Medical Centre, Burlington, VT, USA.; VA Long Beach Healthcare System, Long Beach, CA, USA.; University of British Columbia, Vancouver, BC, Canada.; Mayo Clinic Arizona, Scottsdale, AZ, USA.; Department of Urology, UT Southwestern Medical Centre, University of Texas Southwestern, Dallas, TX, USA.; Icahn School of Medicine at Mount Sinai, New York, NY, USA.

DOI: 10.1111/bju.14360

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MeSH Terms: Ablation Techniques, Adenoma, Aged, Endosonography, Hemostasis, Surgical, Humans, Length of Stay, Male, Middle Aged, Operative Time, Organ Size, Postoperative Hemorrhage, Prospective Studies, Prostate, Prostatic Hyperplasia, Prostatic Neoplasms, Prostatism, Severity of Illness Index, Surveys and Questionnaires, Water