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The FloStent™ prostatic stent is a safe and effective treatment for benign prostatic hyperplasia (BPH), significantly improving urinary symptoms and flow rate in men with LUTS.

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Area of Science:

  • Urology
  • Medical Devices
  • Prosthetics

Background:

  • Benign prostatic hyperplasia (BPH) causes lower urinary tract symptoms (LUTS).
  • Novel nitinol prostatic stents offer potential treatment options.
  • Evaluating new devices like FloStent™ is crucial for BPH management.

Purpose of the Study:

  • To assess the feasibility and safety of the FloStent™ nitinol prostatic stent.
  • To evaluate the FloStent™ in men experiencing LUTS due to BPH.

Main Methods:

  • A multi-center, single-arm study.
  • 15 men aged ≥45 with BPH underwent FloStent™ implantation.
  • Evaluated implantability, tolerability, retrievability, IPSS, Qmax, PVR, and AEs over 52 weeks.

Main Results:

  • Successful implantation in all participants.
  • No postoperative catheterization required.
  • Significant improvements in International Prostate Symptom Score (IPSS) and peak urinary flow rate (Qmax).
  • 13 resolved adverse events (AEs) with no serious complications.
  • Safe device retrieval up to one year post-implantation.

Conclusions:

  • FloStent™ demonstrates safety and efficacy for BPH treatment.
  • Provides significant symptom relief and improved urinary function.
  • Further large-scale, randomized trials are recommended to confirm long-term outcomes.