Mihir Desai1, Mo Bidair2, Kevin C Zorn3, 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, Naeem Bhojani3. 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 Center, Université de Montréal, Montreal, QC, Canada. 4. Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, USA. 5. Virginia Urology, Richmond, VA, USA. 6. University of Toronto - University Health Network, 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 Center, 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. UT Southwestern Medical Center, Department of Urology, University of Texas Southwestern, Dallas, TX, USA. 16. Icahn School of Medicine at Mount Sinai, New York, NY, USA.
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.
RCT Entities:
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.
Authors: Kevin C Zorn; Mohamed Bidair; Andrew Trainer; Andrew Arther; Eugene Kramolowsky; Mihir Desai; Leo Doumanian; Dean Elterman; Ronald P Kaufman; James Lingeman; Amy Krambeck; Gregg Eure; Gopal Badlani; Mark Plante; Edward Uchio; Greg Gin; S Larry Goldenberg; Ryan Paterson; Alan So; Mitchell Humphreys; Claus Roehrborn; Steven Kaplan; Jay Motola; Naeem Bhojani Journal: BJUI Compass Date: 2021-10-28
Authors: Kevin C Zorn; S Larry Goldenberg; Ryan Paterson; Alan So; Dean Elterman; Naeem Bhojani Journal: Can Urol Assoc J Date: 2018-10-15 Impact factor: 1.862
Authors: David-Dan Nguyen; Neil Barber; Mo Bidair; Peter Gilling; Paul Anderson; Kevin C Zorn; Gopal Badlani; Mitch Humphreys; Steven Kaplan; Ronald Kaufman; Alan So; Ryan Paterson; Larry Goldenberg; Dean Elterman; Mihir Desai; Jim Lingeman; Claus Roehrborn; Naeem Bhojani Journal: BJU Int Date: 2019-11-08 Impact factor: 5.588
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