Long-Term Data Showcase the Therapeutic Potential of Optilume

Over the past decade, the treatment options for benign prostatic hyperplasia (BPH) have been transformed by minimally invasive therapies that offer quick symptom relief and lower complication rates while aiming to preserve sexual function. The Optilume catheter system, which combines mechanical dilation of the prostatic urethra with localized delivery of paclitaxel to maintain long-term urethral patency and improve urine flow, has gained popularity as a safe, effective option for addressing residual symptoms associated with BPH. Recent findings presented at the 2026 Annual Meeting of the American Urological Association (AUA 2026) in Washington, D.C. showed that treatment with the Optilume BPH catheter system maintained symptomatic relief and functional improvements long-term, up to 5 years, in patients with BPH. 

Optilume has been studied in two clinical trials that enrolled more than 200 men with symptomatic BPH treated at multiple clinics in Latin America, Canada, and the United States. The primary efficacy analysis from the EVEREST study showed that the Optilume BPH catheter system alleviated lower urinary tract symptoms and achieved significant improvements in urine flow and quality of life in patients treated at six centers in Latin America. Data collected from the 53 participants who completed the 5-year follow-up assessment showed that the improvements achieved with Optilume were maintained over time, with very low rates of retreatment. Among the three patients who pursued additional therapies for BPH (3.8%), one individual needed surgical retreatment and two participants reinitiating pharmacotherapy. 

Significant improvements in symptom scores were sustained long-term, with International Prostate Symptom Scores (IPSS) improving from 22.3 at baseline to 11.1 at 5 years. Functional improvement was also maintained, with the peak urinary flow rate (Qmax) value increasing from an average of 10.9 mL/sec at baseline to 17.8 mL/sec at the 5-year follow-up. Quality of life metrics, including IPSS QoL and BPH-II scores, continued to improve from baseline throughout the follow-up period. 

A separate analysis from the PINNACLE study, in which 148 patients treated at 18 centers in the United States and Canada were randomized to the Optilume BPH catheter system (100 participants) or to sham interventions (48 participants), showed that the improvements achieved with Optilume were maintained up to 3 years. Of the 69 participants who completed the 3-year follow-up assessment, only six men underwent additional surgical procedures. 

Improvements in IPSS were maintained up to 3 years (23.4 vs 10.3; -12.9 improvement) and Qmax values improved from 8.9 ml/sec at baseline to 17.1 ml/sec through the 3-year follow-up. Symptom scores and peak urinary flow rate values changed very little between 12 months and the 3-year follow-up. Moreover, no changes were reported in perceived sexual or ejaculatory function.

“Treatment with Optilume BPH results in impressive and durable functional improvements in flow rate and symptomology,” the research team noted. “The peak flow rate nearly doubled from baseline and remained consistently above normal thresholds through 3 years, suggesting long-term efficacy. Minimal surgical retreatment has occurred in the cohort of patients randomized to receive Optilume BPH as part of the pivotal randomized, sham-controlled trial.” 

The final long-term results reinforced the previous findings from both trials, demonstrating that the Optilume BPH catheter system represents a compelling long-term option for the minimally invasive treatment of urinary symptoms associated with BPH.