Minimally-invasive catheter system makes significant strides in tackling benign prostatic hyperplasia

Over the past decade, the therapeutic landscape of benign prostatic hyperplasia (BPH) has been redefined by minimally invasive therapies that provide rapid symptom relief, decrease the rates of complications, and preserve sexual function. Among these, the Optilume BPH catheter system has emerged as a viable method of managing lower urinary tract symptoms associated with BPH.  The Optilume procedure combines mechanical dilation of the prostatic urethra with localized delivery of paclitaxel to maintain long-term urethral patency and improve urine flow.

Optilume has been studied in two clinical trials that enrolled nearly 200 men with symptomatic BPH treated at several medical centers in Latin America, Canada, and the United States. At the 2025 Annual Meeting of the American Urological Association (AUA 2025) in Las Vegas, Nevada, the lead investigators presented updated findings on the long-term efficacy and safety of the Optilume procedure up to 5 years.

An analysis of combined outcomes from the EVEREST and PINNACLE trials showed that individuals with BPH treated with the Optilume procedure experienced significant improvements in symptomatic and functional outcomes, which were maintained up to 2 years. EVEREST is a prospective, non-randomized multicenter study enrolling 80 participants from Latin American countries. PINNACLE, a prospective, multicenter, randomized clinical trial enrolled 148 participants in the United States and Canada to compare the outcomes of Optilume treatment against those of a sham procedure.

The combined analysis showed significant improvements in International Prostate Symptom Scores (IPSS) from 22.9 at baseline to 9.7 at the 2-year follow-up. Peak urinary flow rates increased from 9.8 mL/s at baseline to 18.1 mL/s at 2 years in men who underwent Optilume. Moreover, post-void residual volumes improved from 75 cc at baseline to 56 cc at 2 years. Optilume demonstrated a favorable safety profile and did not affect sexual function. No transfusions, retrograde ejaculation, stress incontinence, or stricture formation were reported in the series, and less than 2% of the participants (3 patients) required surgical retreatment of BPH.

Steven Kaplan, MD, a professor of urology at the Icahn School of Medicine at Mount Sinai, in New York City, presented results from a separate analysis from the PINNACLE study, in which 148 patients treated at 18 centers in the United States and Canada were randomized in a 2:1 fashion to Optilume BPH (100 participants) or to sham interventions (48 participants). Results recorded up to 3 years after the procedures showed that treatment with Optilume BPH resulted in significant and durable functional improvements in flow rate and BPH symptoms. Of the 78 participants who completed the 2-year follow-up in PINNACLE, 4 individuals (4%) required additional surgical management of BPH through the 3-year cutoff of the analysis. Improvement in IPSS scores was maintained through 3 years, and peak urinary flow rates during uroflowmetry (Qmax values) improved from 8.9 mL/sec at baseline to 17.7 mL/sec at the 3-year follow-up. The analysis showed minimal changes in IPSS and Qmax values from 12 months to the 3-year mark.

Kaplan and colleagues also reported that the symptomatic and functional improvements observed in the EVEREST study conducted at six centers in Latin America were maintained up to 5 years among the 53 participants who completed the 5-year follow-up. IPSS scores registered an average improvement of 10.6 points from baseline to 5 years. Quality of life metrics, including IPSS QoL and BPH-II, also showed a steady improvement from baseline. Functional improvements were also maintained, with an average baseline Qmax of 10.9 mL/sec increasing to 17.8mL/sec at the 5-year follow-up.

While the collection of long-term results continues in both studies, intermediate results suggest that Optilume represents a promising option for the long-term management of urinary symptoms associated with BPH.