PD31-08: Long-term Outcomes of Urethral Stricture Treatment with the Optilume Paclitaxel-Coated Balloon: 4-Year Results from the ROBUST I Study

Sean Elliott*, Minneapolis, MN, Ramon Virasoro, Norfolk, VA, Rafael Estrella, Santiago de los Caballeros, Dominican Republic, Merycarla Pichardo, Santo Domingo, Dominican Republic, Ramon Rodríguez Lay, Gustavo Espino, Panama City, Panama, Jessica DeLong, Norfolk, VA

Introduction: Mechanical dilation and direct vision internal urethrotomy are the most common treatments for urethral stricture disease. Although a first-time endoscopic therapy has about 50% success, repeat treatment is rarely successful long-term. We have shown good success with intermediate follow-up of patients treated for recurrent strictures with the Optilume® paclitaxel drug-coated balloon (DCB) and herein report long-term outcomes of a single-arm study.

Methods: After ethics committee approval, men with recurrent (1-4 prior treatments) bulbar strictures = 2cm were treated with the DCB. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was the proportion of subjects with = 50% improvement in International Prostate Symptom Score (IPSS) at 4 years. Subjects receiving secondary treatment were treated as failures. Subjects with IPSS failure but an open stricture on cystoscopy were censored. Secondary outcomes included quality of life, freedom from repeat intervention, erectile function, flow rate, and post-void residual urine volume.

Results: 53 subjects were enrolled and treated; 41 were evaluable for the primary endpoint at 4 years. 43% of men had undergone =2 previous dilations (mean 1.7). There were no treatment-related serious adverse events. At 4 years there were: 29 successes, 11 retreatments, 3 IPSS fail without retreatment, 7 lost to follow-up with low IPSS (censored) and 3 IPSS failure with open stricture on cystoscopy (censored). Success was achieved in 29/43 (67%). Freedom from retreatment was 30/43 (70%).  IPSS including last observation carried forward for the failures improved from a mean of 25.2 at baseline to 8.6 (p < 0.001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function.

Conclusions: Subjects with recurrent bulbar strictures treated with the Optilume DCB exhibited significant improvement in symptomatic and functional outcomes through 4 years post-treatment. The DCB represents a durable treatment option for patients with recurrent strictures who are unwilling or unable to undergo urethroplasty.

Source of Funding: Urotronic, LLC