Anis Assad1, David-Dan Nguyen2, Neil Barber3, Mo Bidair4, Peter Gilling5, Paul Anderson6, Gopal Badlani7, Mitch Humphreys8, Steven Kaplan9, Ronald Kaufman10, Alan So11, Ryan Paterson11, Mihir Desai12, Claus Roehrborn13, Bilal Chughtai14, Kevin C Zorn1, Dean Elterman15, Naeem Bhojani16. 1. Division of Urology, Centre Hospitalier de l'Université de Montréal, Montreal, Canada. 2. Faculty of Medicine and Health Sciences, McGill University, Montreal, Canada. 3. Department of Urology, Frimley Park Hospital, Frimley, UK. 4. San Diego Clinical Trials, San Diego, CA. 5. Department of Urology, Bay of Plenty District Health Board Clinical School, Tauranga, New Zealand. 6. Department of Urology, Royal Melbourne Hospital, Melbourne, Australia. 7. Department of Urology, Wake Forest School of Medicine, Winston-Salem, NC. 8. Department of Urology, Mayo Clinic, Phoenix, AZ. 9. Department of Urology, Mount Sinai Hospital, New York, NY. 10. Division of Urology, Albany Medical College, Albany, NY. 11. Urologic Sciences, University of British Columbia, Vancouver, Canada. 12. Institute of Urology at USC, University of Southern California, Los Angeles, CA. 13. Department of Urology, UT Southwestern Medical Centre, Dallas, TX. 14. Department of Urology, Weill Cornell Medical College of Cornell University, New York, NY. 15. Division of Urology, University of Toronto, Toronto, Canada. 16. Division of Urology, Centre Hospitalier de l'Université de Montréal, Montreal, Canada. Electronic address: naeem.bhojani@gmail.com.
Abstract
OBJECTIVE: To compare the outcomes of Aquablation for small-to-moderate (30-80cc) prostates with the outcomes for large (80-150 cc) prostates at 3-year follow up. METHODS: WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45-80 year with a prostate of 30cc-80cc. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80cc-150cc. We compare 36-mo outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation. RESULTS: International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.5 at 36-month, with 36-mo reductions of 14.4 and 16.3 points, respectively (P = .247). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 18.5 cc/sec, respectively (P = .552) at 36-mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 3 year, 98% and 94% of treated patients were BPH medication-free in WATER and WATER II, respectively (P = .038). At 3yr, 96% and 97% of treated patients were free from surgical retreatment in WATER and WATER II, respectively (P = .613). CONCLUSIONS: Three-year follow-up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.
OBJECTIVE: To compare the outcomes of Aquablation for small-to-moderate (30-80cc) prostates with the outcomes for large (80-150 cc) prostates at 3-year follow up. METHODS: WATER is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP in the treatment of LUTS/BPH in men 45-80 year with a prostate of 30cc-80cc. WATER II is a prospective, multicenter, single-arm international clinical trial of Aquablation in men with a prostate of 80cc-150cc. We compare 36-mo outcomes amongst 116 WATER and 101 WATER II study subjects undergoing Aquablation. RESULTS: International Prostate Symptom Score (IPSS) scores improved from 22.9 and 23.2 at baseline in WATER and WATER II, respectively, to 8.0 and 6.5 at 36-month, with 36-mo reductions of 14.4 and 16.3 points, respectively (P = .247). At baseline, urinary flow rate (Qmax) was 9.4 and 8.7 cc/sec in WATER and WATER II, improving to 20.6 and 18.5 cc/sec, respectively (P = .552) at 36-mo. Improvements in both IPSS and Qmax were immediate and sustained throughout follow-up. At 3 year, 98% and 94% of treated patients were BPH medication-free in WATER and WATER II, respectively (P = .038). At 3yr, 96% and 97% of treated patients were free from surgical retreatment in WATER and WATER II, respectively (P = .613). CONCLUSIONS: Three-year follow-up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.