Peter J Gilling1, Neil Barber2, Mohamed Bidair3, Paul Anderson4, Mark Sutton5, Tev Aho6, Eugene Kramolowsky7, Andrew Thomas8, Barrett Cowan9, Claus Roehrborn10. 1. Tauranga Urology Research, Tauranga, New Zealand. Electronic address: peter@urobop.co.nz. 2. Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, UK. 3. San Diego Clinical Trials, San Diego, CA. 4. Royal Melbourne Hospital, Melbourne, Australia. 5. Houston Metro Urology, Houston, TX. 6. Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, UK. 7. Virginia Urology, Richmond, VA. 8. Princess of Wales Hospital, Bridgend, Wales, UK. 9. Urology Associates, P.C., Englewood, CO. 10. UT Southwestern Medical Center, Department of Urology, University of Texas Southwestern, Dallas, TX.
Abstract
OBJECTIVE: To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) METHODS: This double-blinded, multicenter prospective randomized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to eitherelectrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications. RESULTS:BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6% within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related adverse events after month 6. CONCLUSION: The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low. (ClinicalTrials.gov number, NCT02505919).
RCT Entities:
OBJECTIVE: To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) METHODS: This double-blinded, multicenter prospective randomized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either electrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications. RESULTS: BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6% within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related adverse events after month 6. CONCLUSION: The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low. (ClinicalTrials.gov number, NCT02505919).
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: 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