Post-marketing surveillance data presented at the Japan Urological Association (JUA) Annual Meeting demonstrate the safety and efficacy of aquablation therapy in Japanese men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). is supported.1
“The data presented at JUA demonstrate the global reach of aquablation therapy and its safety and effectiveness in treating men across geographic regions and demographics,” said Reza, CEO of PROCEPT BioRobotics. Dr. Zadno said in a news release.1 “The reproducible results observed in numerous cases of real-world aquablation therapy continue to support a paradigm shift in the surgical treatment of benign prostatic hyperplasia.”
Overall, the results of the actual study showed that the mean International Prostate Symptom Score (IPSS) improved, from a mean score of 18 (SD, 9) at baseline to a mean score of 7 (SD, 5) at 3 months. I showed that. follow up. Additionally, study results showed improvement in quality of life scores, from a baseline mean score of 5 (SD, 1) to a mean score of 2 (SD, 2) at 3-month follow-up.
Regarding safety, there were no reports of incontinence when using the pads or serious device-related adverse events among all patients.
In total, 103 Japanese men with BPH-related LUTS were enrolled and treated in the post-marketing study. The mean age of the patients was 71 years (SD, 7 years), and the mean prostate volume was 82 mL (range, 33 mL to 242 mL). Of all participants, 58% were receiving treatment for benign prostatic hyperplasia, 1% had previously undergone surgery for benign prostatic hyperplasia, and 26% had ever used a retention catheter at the time of study entry. Ta.
“It was an honor to give a presentation on the latest treatment exclusively for Japanese men with LUTS caused by benign prostatic hyperplasia,” Nobuyuki Hinata, M.D., professor and president of Hiroshima University Hospital in Japan, said in a news release.1 “The results showed that the safety of modern aquablation surgery in Japanese men is exceptional across a wide range of prostate sizes, with significant symptom relief. [These] The data is consistent with numerous global publications and real-world data over 50,000 surgeries. ”
In August 2023, the therapy's developer, PROCEPT BioRobotics, announced that it had completed Japan's first commercial aquablation procedure as part of a post-market surveillance study.2 The surgery was successfully completed at Japan's Urology Hospital and Itabashi Central Medical Center.
A news release about the launch of this study states:2 Zadono added: “We see Japan as a very promising market for the introduction of aquablation therapy, with its long history of introducing new and innovative technologies while prioritizing patient outcomes. “We intend to lead the way, similar to our approach in the United States,” he added. With solid clinical data and support from key opinion leaders in Japan, we are setting the stage for dynamic and lasting commercial success. ”
References
1. Latest abstract presented at the annual meeting of the Japanese Urological Association on the results of aquablation therapy for Japanese men 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 presents Japan's first commercial aquablation therapy procedure. 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