Dean Elterman, Ingrid Perscky, Ruben Urena, Alia Codelia-Anjum, Adam Kadlec, Bilal Chughtai
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Feasibility and safety study of the Flostent™ system (RAPID-I).
Introduction: This study aimed to evaluate the feasibility and safety of the FloStent™, a novel nitinol prostatic stent, in men with LUTS secondary to BPH.
Materials and methods: This multi-center, single-arm, one-year study included men aged ≥45 with BPH. Participants underwent FloStent™ implantation using a flexible cystoscope. The primary endpoints were device implantability, tolerability, and device retrievability. Secondary assessments included International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), post-void residual (PVR), and adverse events (AEs) at follow-ups over 52 weeks.
Results: The study enrolled 15 participants with a mean age of 58.1 years. All attempts at implantation were successful. Postoperative catheterization was not required in any patient. Significant improvements were observed in IPSS and Qmax. Thirteen AEs were reported, all resolved, with no serious complications. Device retrieval was safely performed using standard urological equipment up to one-year post-implantation.
Conclusions: This preliminary study indicates that the FloStent™ is a safe and effective treatment option for BPH, providing significant symptom relief and improved urinary function with a favorable risk profile. Further research, including larger, randomized controlled trials, are needed to validate these findings and establish the long-term efficacy and safety of the FloStent™ device.
期刊介绍：
Prostate Cancer and Prostatic Diseases covers all aspects of prostatic diseases, in particular prostate cancer, the subject of intensive basic and clinical research world-wide. The journal also reports on exciting new developments being made in diagnosis, surgery, radiotherapy, drug discovery and medical management.
Prostate Cancer and Prostatic Diseases is of interest to surgeons, oncologists and clinicians treating patients and to those involved in research into diseases of the prostate. The journal covers the three main areas - prostate cancer, male LUTS and prostatitis.
Prostate Cancer and Prostatic Diseases publishes original research articles, reviews, topical comment and critical appraisals of scientific meetings and the latest books. The journal also contains a calendar of forthcoming scientific meetings. The Editors and a distinguished Editorial Board ensure that submitted articles receive fast and efficient attention and are refereed to the highest possible scientific standard. A fast track system is available for topical articles of particular significance.
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