Urology · 2025
First Use of the FloStent™ for Catheter-dependent Urinary Retention Secondary to Benign Prostatic Hyperplasia: Additional Results From the RAPID I Study.
СтатьяКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Chughtai Bilal, Polo Jennifer, Perscky Ingrid, Urena Ruben, Kadlec Adam, Elterman Dean
Аннотация
OBJECTIVE: To describe the performance of the FloStent™ in men with catheter-dependent urinary retention due benign prostatic hyperplasia (BPH) awaiting transurethral resection of the prostate (TURP). The FloStent™ is a novel device for treatment of BPH, that can be implanted and retrieved with any flexible cystoscope.
METHODS: 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 lower urinary tract symptoms. 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 12weeks, after which the device was removed, and subjects underwent TURP as previously indicated.
RESULTS: All 11 participants achieved catheter-free status immediately postprocedure. Baseline characteristics included mean age 69.0years, prostate size 65.3 mL, prostate-specific antigen 8.3ng/mL, serum creatinine 1.0mg/dL, and prostatic urethral length 3.4 cm. At 3months, 8 of 11 (72.7%) remained catheter-free. Among those, mean International Prostate Symptom Score was 6.4 ± 6.6, Quality of Life score 0.75 ± 1.75, Qmax 9.5 ± 4.8mL/s, and postvoid residual 105.4 ± 265.1 mL. Pain scores were uniformly 0 across all timepoints. Seven adverse events occurred in five subjects, all nonserious and self-limited.
CONCLUSION: 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.
METHODS: 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 lower urinary tract symptoms. 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 12weeks, after which the device was removed, and subjects underwent TURP as previously indicated.
RESULTS: All 11 participants achieved catheter-free status immediately postprocedure. Baseline characteristics included mean age 69.0years, prostate size 65.3 mL, prostate-specific antigen 8.3ng/mL, serum creatinine 1.0mg/dL, and prostatic urethral length 3.4 cm. At 3months, 8 of 11 (72.7%) remained catheter-free. Among those, mean International Prostate Symptom Score was 6.4 ± 6.6, Quality of Life score 0.75 ± 1.75, Qmax 9.5 ± 4.8mL/s, and postvoid residual 105.4 ± 265.1 mL. Pain scores were uniformly 0 across all timepoints. Seven adverse events occurred in five subjects, all nonserious and self-limited.
CONCLUSION: 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.