To describes the performance of the FloStent in men with catheter-dependent urinary retention due BPH awaiting transurethral resection of the prostate (TURP). The FloStent™ is a novel device for treatment of benign prostatic hyperplasia (BPH), that can be implanted and retrieved with any flexible cystoscope.
The RAPID I study was a first-in-human clinical trial designed to evaluate the clinical performance of the FloStent™. One arm of the study treated men with LUTS. In a separate and distinct arm of the study, reported here, 11 men with BPH-related urinary retention and indwelling catheters were enrolled and scheduled for FloStent implantation. All underwent outpatient device placement. Follow-up visits occurred at 2, 6, and 12 weeks, after which the device was removed, and subjects underwent TURP as previously indicated.
All 11 participants achieved catheter-free status immediately post-procedure. Baseline characteristics included mean age 69.0 years, prostate size 65.3 mL, PSA 8.3 ng/mL, serum creatinine 1.0 mg/dL, and prostatic urethral length 3.4 cm. At 3 months, 8 of 11 (72.7%) remained catheter-free. Among those, mean IPSS was 6.4 ± 6.6, QOL score 0.75 ± 1.75, Qmax 9.5 ± 4.8 mL/s, and PVR 105.4 ± 265.1 mL. Pain scores were uniformly 0 across all timepoints. Seven adverse events occurred in five subjects, all non-serious and self-limited.
FloStent™ enabled catheter-free voiding in the majority of subjects, with excellent tolerability. This approach may offer an effective interim solution for patients awaiting TURP.
Urology. 2025 Sep 16 [Epub ahead of print]
Bilal Chughtai, Jennifer Polo, Ingrid Perscky, Ruben Urena, Adam Kadlec, Dean Elterman
Department of Urology, Northwell Health, Syosset, New York; Department of Urology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York. Electronic address: ., Department of Urology, Northwell Health, Syosset, New York., Department of Urology, Pacifica Salud, Hospital Punta Pacifica, Panama, Panama., Department of Urology, Northwell Health., Rivermark Medical, Inc., Division of Urology, Department of Surgery, University of Toronto, Ontario, Canada.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40967370