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Introduction <p>This study aimed to evaluate the feasibility and safety of the FloStent™, a novel nitinol prostatic stent, in men with LUTS secondary to BPH.</p> Materials and methods <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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Feasibility and safety study of the Flostent™ system (RAPID-I)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月21日

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  • Dean Elterman,
  • Ingrid Perscky,
  • Ruben Urena,
  • Alia Codelia-Anjum,
  • Adam Kadlec,
  • Bilal Chughtai

摘要

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.