Peter Gilling1, Neil Barber2, Mohamed Bidair3, Paul Anderson4, Mark Sutton5, Tev Aho6, Eugene Kramolowsky7, Andrew Thomas8, Barrett Cowan9, Ronald P Kaufman10, Andrew Trainer11, Andrew Arther11, Gopal Badlani12, Mark Plante13, Mihir Desai14, Leo Doumanian14, Alexis E Te15, Mark DeGuenther16, Claus Roehrborn17. 1. Tauranga Urology Research, Tauranga, New Zealand. 2. Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, United Kingdom. 3. San Diego Clinical Trials, San Diego, California. 4. Royal Melbourne Hospital, Melbourne, Australia. 5. Houston Metro Urology, Houston, Texas. 6. Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, United Kingdom. 7. Virginia Urology, Richmond, Virginia. 8. Princess of Wales Hospital, Bridgend, Wales, United Kingdom. 9. Urology Associates, P.C., Englewood, Colorado. 10. Albany Medical College, Albany, New York. 11. Adult Pediatric Urology and Urogynecology, P.C., Omaha, Nebraska. 12. Wake Forest School of Medicine, Winston-Salem, North Carolina. 13. University of Vermont Medical Center, Burlington, Vermont. 14. Institute of Urology, University of Southern California, Los Angeles, California. 15. Weill Cornell Medical College, New York, New York. 16. Urology Centers of Alabama, Birmingham, Alabama. 17. Department of Urology, Southwestern Medical Center, University of Texas Southwestern, Dallas, Texas. Electronic address: Claus.Roehrborn@utsouthwestern.edu.
Abstract
PURPOSE: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. MATERIALS AND METHODS: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwenttransurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. RESULTS:Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). CONCLUSIONS:Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.
RCT Entities:
PURPOSE: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. MATERIALS AND METHODS: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. RESULTS: Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). CONCLUSIONS: Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.
Authors: J Curtis Nickel; Lorne Aaron; Jack Barkin; Dean Elterman; Mahmoud Nachabé; Kevin C Zorn Journal: Can Urol Assoc J Date: 2018-10 Impact factor: 1.862
Authors: David-Dan Nguyen; Vincent Misraï; Thorsten Bach; Naeem Bhojani; James E Lingeman; Dean S Elterman; Kevin C Zorn Journal: World J Urol Date: 2020-03-02 Impact factor: 4.226
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