Real-world data support safety, efficacy of Aquablation for BPH-related LUTS

Data from a post-market survey presented at the Japanese Urological Association (JUA) Annual Meeting support the safety and efficacy of Aquablation therapy in men in Japan with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).¹

In August 2023, PROCEPT BioRobotics announced the completion of the first commercial Aquablation procedures in Japan as part of the post-market surveillance study.

“The data presented at the JUA showcase the global reach of Aquablation therapy and its safety and effectiveness in treating men across geographic regions and demographics,” said Reza Zadno, PhD, CEO of PROCEPT BioRobotics, in a news release.¹ “The reproducible results observed in numerous real-world Aquablation therapy cases continue to support a paradigm shift in the surgical treatment of BPH.”

Overall, results from the real-world study showed an improvement in the average International Prostate Symptom Scores (IPSS), going from a baseline average of 18 (SD, 9) to an average score of 7 (SD, 5) at 3-month follow-up. Additionally, findings showed an improvement in quality-of-life scores, improving from an average baseline score of 5 (SD, 1) to an average score of 2 (SD, 2) at 3-month follow-up.

Regarding safety, no instances of pad-use incontinence or serious device-related adverse events were reported among all patients.

In total, the post-market study enrolled and treated 103 Japanese men with BPH-related LUTS. The average age of patients was 71 (SD, 7), with an average prostate volume of 82 mL (range, 33 mL-242 mL). Among all participants, 58% were on BPH medication, 1% had received prior BPH surgery, and 26% had prior catheter use for retention at study entry.

“It was an honor to deliver the late-breaking presentation that treated only Japanese men with LUTS due to BPH,” said Nobuyuki Hinata, MD, professor and chairman at Hiroshima University Hospital in Japan, in the news release.¹ “The results showed the contemporary Aquablation procedural safety in Japanese men is exceptional in a broad range of prostate sizes along with significant symptom reduction. [These] data align with the numerous global publications and real-world data that have eclipsed 50,000 procedures.”

In August 2023, PROCEPT BioRobotics, the developer of the therapy, announced the completion of the first commercial Aquablation procedures in Japan as part of the post-market surveillance study.² The procedures were successfully completed at Oita Urology Hospital and Itabashi Chuo Medical Center in Japan.

In a news release on the study launch,² Zadno added, "We view Japan as a very promising market for the adoption of Aquablation therapy, which has a long history of adopting new, innovative technologies, while prioritizing patient outcomes. Similar to our approach in the US, we intend to pave the way in Japan with solid clinical data and support from key opinion leaders, setting the stage for a dynamic and lasting commercial success.”

References

1. Late Breaking Abstract presented at the Japanese Urological Association Annual Meeting on Aquablation therapy outcomes for men in Japan with lower urinary tract symptoms due to benign prostatic hyperplasia. News release. PROCEPT BioRobotics April 29, 2024. Accessed April 30, 2024. https://ir.procept-biorobotics.com/news-releases/news-release-details/late-breaking-abstract-presented-japanese-urological-association

2. PROCEPT BioRobotics announces first commercial Aquablation Therapy procedures in Japan. News release. PROCEPT BioRobotics. August 22, 2023. Accessed April 30, 2024. https://ir.procept-biorobotics.com/news-releases/news-release-details/procept-bioroboticsr-announces-first-commercial-aquablation