Aqua-Ablation for BPH - Subgroup Examination
Mark Plante, MD, FRCS, FACS
UVM, Burlington, VT
BACKGROUND: High pressure water jet-based prostate resection, for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia, may provide much needed reproducible outcomes for patients suffering from BPH related LUTS. 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. METHODS: We conducted prespecified and 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. RESULTS: 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. CONCLUSIONS: 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.
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