Does size matter? Long-term outcomes after treatment of bulbar urethral strictures with the Optilume drug-coated balloon
Mélanie Aubé-Peterkin1, Sean Elliott2, Ramón Virasoro3, Jessica DeLong3, Rafael E. Estrella4, Merycarla Pichardo5, Ramón Rodriguez Lay6, Gustavo Espino7.
1Division of Urology, Department of Surgery, McGill University Health Centre, Montreal, QC, Canada; 2Urology, University of Minnesota, Minneapolis, MN, United States; 3Urology, Eastern Virginia Medical School, Norfolk, VA, United States; 4Urology, Clinica Union Medica, Santiago de los Caballeros, Dominican Republic; 5Urology, URUS, Santo Domingo, Dominican Republic; 6Urology, Urology Royal Center, Panama City, Panama; 7Urology, Centro Especializado San Fernando, Panama City, Panama
Introduction: Stricture dilation with the Optilume drug-coated balloon (DCB) combines the mechanical dilation effect of a standard dilation balloon with the delivery of a controlled dose of paclitaxel circumferentially along the length of the treated segment. Successful drug delivery may be influenced by the relative sizing of the DCB to the urethra. Long-term outcomes for subjects treated with different sized DCBs in the bulbar urethra are reported here.
Methods: Men with recurrent bulbar strictures ≤2 cm with 1–4 prior endoscopic treatments were treated with the Optilume DCB. Long-term endpoints included freedom from repeat intervention, International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), and functional success, defined as the proportion of subjects experiencing a ≥50% improvement in IPSS without repeat intervention. The first 25 consecutive subjects meeting eligibility criteria were treated with a 24F Optilume DCB, while the next 28 subjects were treated with a 30F Optilume DCB.
Results: Of the 53 subjects enrolled and treated, 41 were evaluable at the four-year followup (n=20 24F, n=21 30F). Demographics and stricture characteristics were similar between the two groups. Average IPSS improved from 25.2 at baseline to 7.8 at four years for the overall group, with significantly better scores at four years in the patients treated with the 30F DCB compared to 24F (3.8 vs. 12.1, p=0.004). Qmax followed a similar trend, with patients treated with the 30F DCB exhibiting significantly better Qmax values through four years (18.4 vs. 9.2 mL/sec). Functional success also favored the 30F DCB (83% vs. 50%).
Conclusions: Treatment of bulbar urethral strictures with the Optilume DCB may benefit from the use of the larger 30F DCB diameter. Published results from the ROBUST III study describe a similar benefit for the Optilume DCB when compared to those treated with a bare 30F balloon, indicating the benefit from a 30F DCB may lie more with the achievement of better drug delivery to the urethral mucosa.
