@article{DeLong_Ehlert_Erickson_Robertson_Virasoro_Elliott_2022, title={One-Year Outcomes of the ROBUST II Study Evaluating the Use of a Drug-Coated Balloon for Treatment of Urethral Stricture}, volume={3}, url={https://www.siuj.org/index.php/siuj/article/view/159}, DOI={10.48083/MLXK5817}, abstractNote={<p>Objectives: To report 1-year results of the ROBUST II study investigating the safety and efficacy of a paclitaxelcoated<br>balloon for the treatment of recurrent urethral strictures.<br>Methods: Subjects were adult men with a single anterior urethral stricture ≤ 3 cm in length and at least 2 prior<br>stricture treatments. After treatment with the Optilume urethral drug-coated balloon (DCB), subjects were followed<br>through 1 year. The primary safety endpoint was the rate of treatment-related serious complications at 90 days postprocedure.<br>Efficacy outcomes included symptomatic assessments, erectile function measured using the International<br>Index of Erectile Function (IIEF), Qmax, and anatomic success.<br>Results: Sixteen men with an average of 4.1 prior dilations were treated with the DCB. Anatomic success was<br>achieved at 6 months in 73%. Average IPSS improved from 18.4 to 6.0 at 1 year (P &lt; 0.001). Qmax improved from<br>6.9 mL/sec to 20.8 mL/sec (P &lt; 0.001). There was no change in IIEF. Four subjects received additional treatment within<br>1 year. There were no treatment-related serious complications.<br>Conclusions: Short-term follow-up of men with urethral stricture treated with the Optilume DCB showed<br>durable anatomic results at 6 months and sustained symptomatic improvement through 1 year. Treatment with<br>the device was safe.</p&gt;}, number={1}, journal={Société Internationale d’Urologie Journal}, author={DeLong, Jessica M. and Ehlert, Michael J. and Erickson, Bradley A. and Robertson, Kaiser J. and Virasoro, Ramón and Elliott, Sean P.}, year={2022}, month={Jan.}, pages={21-27} }