Presentation Authors: Peter Gilling*, Tauranga, New Zealand, Claus Roehrborn, Dallas, TX
Introduction: Early reports of Aquablation (robotic, high-velocity waterjet prostate resection) for lower urinary tract symptoms due to benign prostatic hyperplasia suggest efficacy similar to that of TURP. We compare the safety and efficacy of prostate ablation using Aquablation (A) vs TURP (T).
Methods: In this randomized, blinded, multi-center phase III trial, men with moderate-to-severe LUTS related to BPH were assigned to TURP or Aquablation. The primary safety endpoint was the occurrence of persistent CD Grade 1 or Grade 2 or higher operative complications at 3 months. The primary efficacy endpoint was the reduction in IPSS score at 6 months. Here we report 12 month data.
Results: The mean baseline IPSS score, demographic profile, and mean prostate volume (T: 52 mL vs. A: 54 mL, p=0.31) were similar in both arms. Mean operative time was equivalent between the two groups (T: 35.5 vs. A:32.8 minutes, p=0.28), but mean resection time was significantly less in the Aquablation group (27 vs. 4 minutes, p < .0001). The primary safety endpoint at 3 months occurred in 26% of Aquablation subjects and 42% of TURP subjects demonstrating superiority of Aquablation versus TURP. The overall rate of persistent anejaculation in sexually active men in the first 6 months occurred in 10% of Aquablation subjects and 38% of TURP subjects demonstrating superiority of Aquablation versus TURP. Mean IPSS scores decreased from 22.9 at baseline to 5.9 at 6 months in the Aquablation group and from 22.2 at baseline to 6.8 in the TURP group demonstrating non-inferiority for the primary efficacy endpoint. The IPSS change scores for each arm at 12 months was 15.1 points (p=0.9940). The change in Qmax at 12 months was 10.3 for Aquablation and 10.6 for TURP (p=ns).Urodynamics studies were performed in 64 of the participating subjects at baseline and 6 month follow-up. At baseline Pdet/Qmax was 71.1 and 76.2 cm H20 in the Aquablation and TURP groups, respectively (p=.5393). At 6-month follow-up, Pdet/Qmax decreased by 36 and 37 cm H20 respectively (p < .0001) compared to baseline for both arms) with no significant difference in decrease across groups (p=.8919).
Conclusions: Aquablation showed non-inferior symptom relief compared to TURP but with a lower risk of sexual dysfunction. The change in IPSS and Qmax at 12 months show similar durability for both Aquablation and TURP.
Source of Funding: Procept Biorobotics Ltd