Mihir Desai1, Mo Bidair2, Naeem Bhojani3, Andrew Trainer4, Andrew Arther4, Eugene Kramolowsky5, Leo Doumanian1, Dean Elterman6, Ronald P Kaufman7, James Lingeman8, Amy Krambeck8, Gregg Eure9, Gopal Badlani10, Mark Plante11, Edward Uchio12, Greg Gin12, Larry Goldenberg13, Ryan Paterson13, Alan So13, Mitch Humphreys14, Claus Roehrborn15, Steven Kaplan16, Jay Motola16, Kevin C Zorn3. 1. Institute of Urology, University of Southern California, Los Angeles, CA, USA. 2. San Diego Clinical Trials, San Diego, CA, USA. 3. University of Montreal Hospital Centre, University of Montréal, Montreal, QC, Canada. 4. Adult Paediatric Urology and Urogynecology, P.C., Omaha, NE, USA. 5. Virginia Urology, Richmond, VA, USA. 6. University Health Network University of Toronto, Toronto, ON, Canada. 7. Albany Medical College, Albany, NY, USA. 8. Indiana University Health Physicians, Indianapolis, IN, USA. 9. Urology of Virginia, Virginia Beach, VA, USA. 10. Wake Forest School of Medicine, Winston-Salem, NC, USA. 11. University of Vermont Medical Centre, Burlington, VT, USA. 12. VA Long Beach Healthcare System, Long Beach, CA, USA. 13. University of British Columbia, Vancouver, BC, Canada. 14. Mayo Clinic Arizona, Scottsdale, AZ, USA. 15. Department of Urology, UT Southwestern Medical Centre, University of Texas Southwestern, Dallas, TX, USA. 16. Icahn School of Medicine at Mount Sinai, New York, NY, USA.
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).
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).
Authors: Iman Sadri; Adel Arezki; Félix Couture; David-Dan Nguyen; Russell Schwartz; Ahmed S Zakaria; Dean Elterman; Enrique Rijo; Vincent Misrai; Thorsten Bach; Claus G Roehrborn; Kevin C Zorn Journal: World J Urol Date: 2020-08-01 Impact factor: 4.226
Authors: Dean Elterman; Thorsten Bach; Enrique Rijo; Vincent Misrai; Paul Anderson; Kevin C Zorn; Naeem Bhojani; Albert El Hajj; Bilal Chughtai; Mihir Desai Journal: BJU Int Date: 2020-01-24 Impact factor: 5.588