Aquablation, a waterjet-based prostate resection, has been used for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. The hypothesis that BPH surgery standardized with robotic execution may have a more pronounced benefit in certain subgroups such as subjects with more challenging anatomies (e. g., large prostates, large middle lobes) and subjects with moderate BPH has not yet been determined.
We conducted prespecified and post-hoc exploratory subgroup analyses from a double-blind, multicenter prospective randomized controlled trial comparing transurethral resection of the prostate using either standard electrocautery (TURP) or robotic waterjet (Aquablation) to determine whether certain baseline factors predicted more marked responses after Aquablation as compared to TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or Grade 2 or higher operative complications.
For men with larger prostates 50-80g, mean IPSS reduction was 4 points larger after Aquablation compared to TURP (p=.0099), a larger difference than the overall result (1.8 points, p=.1347). Similarly, the primary safety endpoint difference (20% vs. 46% [26% difference, p=.0082]) was larger for men with large prostate compared to the overall result (26% vs. 42% [16% difference, p=.0149]). Postoperative anejaculation was also less common after Aquablation compared to TURP in sexually active men with large prostates (2% vs. 41%, p=.0001) vs. the overall results (10% vs. 36%, p=.0003). Exploratory analysis showed larger IPSS changes after Aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline Qmax, and men with elevated (>100) post-void residual.
In patients with moderate-to-severe LUTS due to BPH and larger, more complex prostates, Aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with Aquablation may overcome the increased outcome variability in more complex anatomy that result in superior symptom score reduction. (ClinicalTrials. gov number, NCT02505919). This article is protected by copyright. All rights reserved.
BJU international. 2018 Jun 04 [Epub ahead of print]
Mark Plante, Peter Gilling, Neil Barber, Mohamed Bidair, Paul Anderson, Mark Sutton, Tev Aho, Eugene Kramolowsky, Andrew Thomas, Barrett Cowan, Ronald P Kaufman, Andrew Trainer, Andrew Arther, Gopal Badlani, Mihir Desai, Leo Doumanian, Alexis E Te, Mark DeGuenther, Claus Roehrborn
University of Vermont Medical Center, Burlington, VT, US., Tauranga Urology Research, Tauranga, New Zealand., Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, UK., San Diego Clinical Trials, San Diego, CA, US., Royal Melbourne Hospital, Melbourne, Australia., Houston Metro Urology, Houston, TX, US., Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, UK., Virginia Urology, Richmond, VA, US., Princess of Wales Hospital, Bridgend, Wales, UK., Urology Associates, P.C, Englewood, CO, US., Albany Medical College, Albany, NY, US., Adult Pediatric Urology& Urogynecology, P.C, Omaha, NE, US., Wake Forest School of Medicine, Winston-Salem, NC, US., University of Southern California, Institute of Urology, Los Angeles, CA, US., Weill Cornell Medical College, New York, NY, US., Urology Centers of Alabama, Birmingham, AL., UT Southwestern Medical Center, Department of Urology, University of Texas Southwestern, Dallas, TX, US.