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Purpose <p>The WATER and WATER-II clinical trials of Aquablation demonstrated effectiveness for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostate volumes (PV) 30–80 and 80–150&#xa0;mL, respectively. In this study, we compare real-world Aquablation outcomes of men with similar PVs to results from WATER/WATER-II.</p> Methods <p>We retrospectively analyzed 1946 consecutive men from the International Collaborative Aquablation Research Urology Society (ICARUS) database between 2018 and 2024 with PV ≤ 150&#xa0;mL who underwent Aquablation at one of four international centers. Baseline characteristics, functional outcomes and complications were compared to data from WATER/WATER-II using ANOVA and Kruskal-Wallis tests.</p> Results <p>From the ICARUS database, 1069 men (PV ≤ 80&#xa0;mL) were compared to 116 men (WATER), and 877 men (PV 80–150&#xa0;mL) were compared to 101 men (WATER-II). As expected, there were slight differences in baseline characteristic between cohorts. Quality of Life and International Prostate Symptom Scores (IPSS) were slightly higher at some timepoints in the real-world (E.g. IPSS at 3-months: ICARUS-I 9.9 ± 6.9 vs. WATER 7.0 ± 5.7, <i>p</i> &lt; 0.001). Anejaculation rates, Qmax flow rates, and post-void residuals at 3 months were consistent across cohorts. Transfusion rates were significantly lower in the real-world large prostate dataset (ICARUS-II 1.3% vs. WATER-II 5.9%, <i>p</i> = 0.01).</p> Conclusion <p>Real-world outcomes of Aquablation are broadly comparable to those observed in the pivotal WATER/WATER-II trials. These findings support its generalizability and effectiveness beyond the rigorous selection criteria of WATER/WATER-II, validating its role as a viable treatment for BPH in routine clinical practice.</p>

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Real-World outcomes of aquablation for benign prostatic hyperplasia: a comparative analysis of the international collaborative aquablation research urology society (ICARUS) database, WATER and WATER-II trials

  • 期刊论文

  • 发表日期：

    2026年2月3日

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  • Nick Lee,
  • David Bouhadana,
  • Jeffrey Sioufi,
  • Anindyo Chakraborty,
  • Liam Murad,
  • Shawn Marhamati,
  • Tiago Rodrigues,
  • Brian T. Helfand,
  • Juan J. Quintas,
  • Nicholas J. Corsi,
  • Hazem Elmansy,
  • Alexander P. Glaser,
  • Kevin C. Zorn

摘要

Purpose

The WATER and WATER-II clinical trials of Aquablation demonstrated effectiveness for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostate volumes (PV) 30–80 and 80–150 mL, respectively. In this study, we compare real-world Aquablation outcomes of men with similar PVs to results from WATER/WATER-II.

Methods

We retrospectively analyzed 1946 consecutive men from the International Collaborative Aquablation Research Urology Society (ICARUS) database between 2018 and 2024 with PV ≤ 150 mL who underwent Aquablation at one of four international centers. Baseline characteristics, functional outcomes and complications were compared to data from WATER/WATER-II using ANOVA and Kruskal-Wallis tests.

Results

From the ICARUS database, 1069 men (PV ≤ 80 mL) were compared to 116 men (WATER), and 877 men (PV 80–150 mL) were compared to 101 men (WATER-II). As expected, there were slight differences in baseline characteristic between cohorts. Quality of Life and International Prostate Symptom Scores (IPSS) were slightly higher at some timepoints in the real-world (E.g. IPSS at 3-months: ICARUS-I 9.9 ± 6.9 vs. WATER 7.0 ± 5.7, p < 0.001). Anejaculation rates, Qmax flow rates, and post-void residuals at 3 months were consistent across cohorts. Transfusion rates were significantly lower in the real-world large prostate dataset (ICARUS-II 1.3% vs. WATER-II 5.9%, p = 0.01).

Conclusion

Real-world outcomes of Aquablation are broadly comparable to those observed in the pivotal WATER/WATER-II trials. These findings support its generalizability and effectiveness beyond the rigorous selection criteria of WATER/WATER-II, validating its role as a viable treatment for BPH in routine clinical practice.