FloStent device shows efficacy for acute urinary retention due to BPH

Additional results from the RAPID I study showed that the FloStent device enabled catheter-free voiding with favorable tolerability in men with catheter-dependent urinary retention due to benign prostatic hyperplasia (BPH).¹

According to the authors, these findings suggest that FloStent could serve as an effective interim solution for men who are awaiting transurethral resection of the prostate (TURP).

“We are on the cusp of entering a new era in BPH management with a variety of novel intraprostatic devices and stents, also known as FIT (first-line interventional therapy). FIT aims to provide rapid symptom relief, quicker recovery, fewer [adverse] effects, and better patient outcomes, such as preserving sexual function and avoiding long-term medication adherence issues,” explained senior author Dean S. Elterman, MD, MSc, FRCSC, of the University of Toronto, in correspondence with Urology Times. “Rivermark's FloStent has shown preliminary data demonstrating its ability to be deployed with any flexible cystoscopy to provide symptom improvement. This latest study is the first time a FIT has been used in the setting of urinary retention. It furthers the thesis of Rivermark that the FloStent can be used in a variety of situations, including in the acute setting of urinary retention.”

The first-in-humans RAPID I study was designed to assess the clinical performance of the FloStent device in men with lower urinary tract symptoms and urinary retention due to BPH. In total, the BPH-related urinary retention arm enrolled 11 men with indwelling catheters. All patients were implanted with FloStent and underwent follow-up visits at 2, 6, and 12 weeks. At 12 weeks, the devices were removed, and patients underwent TURP as planned.

At baseline, the average age of participants was 69 years, the average prostate size was 65.3 mL, the average prostate-specific antigen level was 8.3 ng/mL, the average serum creatinine was 1.0 mg/dL, and the average prostatic urethral length was 3.4 cm.

All 11 patients in the study achieved catheter-free status immediately following the procedure. At 3 months, 72.7% (8 of 11) of patients remained catheter-free.

Of those who remained catheter-free at 3 months (study end), the average International Prostate Symptom Score was 6.4 ± 6.6, the average quality of life score was 0.75 ± 1.75, the average Qmax was 9.5 ± 4.8 mL/s, and the average postvoid residual (PVR) was 105.4 ± 265.1 mL. The median PVR was 14 mL, with a range of 0 to 761 mL. The authors noted, “Although 1 outlier contributed to the upper range, the majority demonstrated functional bladder emptying and satisfactory flow.”

Four patients required recatheterization during the follow-up period. Of those, 2 had episodes of urinary retention, 1 failed a voiding trial but passed the follow-up voiding trial and ended the study catheter-free, and 1 patient failed a voiding trial and passed a follow-up voiding trial but requested a catheter due to persistent voiding anxiety.

No patients reported pain during or after the procedure. In total, 7 adverse events were observed across 5 patients (45.5%). No serious adverse events or unanticipated adverse device effects were recorded.

“In our pilot study, every patient was catheter-free the same day after FloStent implantation, and nearly three-quarters remained catheter-free for 3 months. FloStent restored spontaneous urination in men who had been catheter-dependent for months—without pain and with no serious complications,” added lead author Bilal I. Chughtai, MD, of Plainview Hospital, in correspondence with Urology Times. “This early study suggests FloStent could be a safe, minimally invasive therapy for men in acute urinary retention.”

In addition to the RAPID I trial, the FloStent device is also being assessed in the ongoing RAPID-III trial (NCT06849258). This pivotal trial is assessing the safety and efficacy of the FloStent device compared with a sham device in treating men with BPH symptoms.

Elterman concluded, “I envision a time when instead of men coming to the emergency room in retention and having a Foley catheter placed, [that] rather a single-use flexible cystoscope and FloStent would be utilized to fix the problem right then and there.”

REFERENCES

1. Chughtai B, Polo J, Perscky I, Urena R, Kadlec A, Elterman D. First use of the FloStent for catheter-dependent urinary retention secondary to BPH: additional results from the RAPID I study. Urology. Published online September 16, 2025. doi:10.1016/j.urology.2025.09.018

2. A clinical study to evaluate the safety and efficacy of the FloStent in men with benign prostatic hyperplasia symptoms (RAPID-III). ClinicalTrials.gov. Last updated April 27, 2025. Accessed September 18, 2025. https://clinicaltrials.gov/study/NCT06849258