Naeem Bhojani1, Mohamed Bidair2, Kevin C Zorn3, Andrew Trainer4, Andrew Arther4, Eugene Kramolowsky5, Leo Doumanian6, Dean Elterman7, Ronald P Kaufman8, James Lingeman9, Amy Krambeck9, Gregg Eure10, Gopal Badlani11, Mark Plante12, Edward Uchio13, Greg Gin13, Larry Goldenberg14, Ryan Paterson14, Alan So14, Mitch Humphreys15, Steven Kaplan16, Jay Motola16, Mihir Desai6, Claus Roehrborn17. 1. University of Montreal Hospital Center, Université de Montréal, Montreal, Quebec, Canada. Electronic address: Naeem.bhojani@gmail.com. 2. San Diego Clinical Trials, San Diego, CA. 3. University of Montreal Hospital Center, Université de Montréal, Montreal, Quebec, Canada. 4. Adult Pediatric Urology & Urogynecology, P.C., Omaha, NE. 5. Virginia Urology, Richmond, VA. 6. University of Southern California, Institute of Urology, Los Angeles, CA. 7. University of Toronto - University Health Network, Toronto, Canada. 8. Albany Medical College, Albany, NY. 9. Indiana University Health Physicians, Indianapolis, IN. 10. Urology of Virginia, Virginia Beach, VA. 11. Wake Forest School of Medicine, Winston-Salem, NC. 12. University of Vermont Medical Center, Burlington, VT. 13. VA Long Beach Healthcare System, Long Beach, CA. 14. University of British Columbia, Vancouver, Canada. 15. Mayo Clinic Arizona, Scottsdale, AZ. 16. Icahn School of Medicine at Mount Sinai, New York, NY. 17. UT Southwestern Medical Center, Department of Urology, University of Texas Southwestern, Dallas, TX.
Abstract
OBJECTIVE: To report 12-month safety and effectiveness outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume prostates. METHODS: One hundred and one men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent a robotic-assisted Aquablation procedure in a prospective multicenter international clinical trial. Functional and safety outcomes were assessed at 12 months postoperatively. RESULTS: Mean prostate volume was 107 cc (range 80-150). Mean operative time was 37 minutes and mean Aquablation resection time was 8 minutes. The average length of hospital stay following the procedure was 1.6 days. Mean International Prostate Symptom Score improved from 23.2 at baseline to 6.2 at 12 months (P <.0001). Mean International Prostate Symptom Score quality of life improved from 4.6 at baseline to 1.3 at 12-month follow-up (P <.0001). Significant improvements were seen in Qmax (12-month improvement of 12.5 cc/sec) and postvoid residual (drop of 171 cc in those with postvoid residual >100 at baseline). Antegrade ejaculation was maintained in 81% of sexually active men. No patient underwent a repeat procedure for BPH symptoms. There was a 2% de novo incontinence rate at 12 months, and 10 patients did require a transfusion postoperatively while 5 required take back fulgurations. At 12 months, prostate-specific antigen reduced from 7.1 ± 5.9 ng/mL at baseline to 4.4 ± 4.3 ng/mL. CONCLUSION: The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80-150 cc) after 1 year of follow-up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands. ClinicalTrials.gov number, NCT03123250.
OBJECTIVE: To report 12-month safety and effectiveness outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume prostates. METHODS: One hundred and one men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent a robotic-assisted Aquablation procedure in a prospective multicenter international clinical trial. Functional and safety outcomes were assessed at 12 months postoperatively. RESULTS: Mean prostate volume was 107 cc (range 80-150). Mean operative time was 37 minutes and mean Aquablation resection time was 8 minutes. The average length of hospital stay following the procedure was 1.6 days. Mean International Prostate Symptom Score improved from 23.2 at baseline to 6.2 at 12 months (P <.0001). Mean International Prostate Symptom Score quality of life improved from 4.6 at baseline to 1.3 at 12-month follow-up (P <.0001). Significant improvements were seen in Qmax (12-month improvement of 12.5 cc/sec) and postvoid residual (drop of 171 cc in those with postvoid residual >100 at baseline). Antegrade ejaculation was maintained in 81% of sexually active men. No patient underwent a repeat procedure for BPH symptoms. There was a 2% de novo incontinence rate at 12 months, and 10 patients did require a transfusion postoperatively while 5 required take back fulgurations. At 12 months, prostate-specific antigen reduced from 7.1 ± 5.9 ng/mL at baseline to 4.4 ± 4.3 ng/mL. CONCLUSION: The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80-150 cc) after 1 year of follow-up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands. ClinicalTrials.gov number, NCT03123250.
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: 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: 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
Authors: Dean Elterman; Peter Gilling; Claus Roehrborn; Neil Barber; Vincent Misrai; Kevin C Zorn; Naeem Bhojani; Alexis Te; Mitch Humphreys; Steven Kaplan; Mihir Desai; Thorsten Bach Journal: BMJ Surg Interv Health Technol Date: 2021-06-23