Optilume® Drug-Coated Balloon May Lower the Re-Treatment Rate Postintervention for Challenging Urethral Stricture Disease in Long-Term Follow-Up: A Prospective Cohort Study.

ABSTRACT

Background: Urethral stricture disease is a common and at times unsatisfying condition that can lead to complications severely impacting a patient's quality of life (QOL). Open urethroplasty remains the gold standard treatment, however it is an invasive and highly specialized procedure. Strictures between 2 and 4 cm in length have been shown to recur at a rate of 50% within 12 months, a rate that typically decreases with each subsequent treatment. The Laborie Optilume drug-coated balloon (DCB) is the first of its kind developed for adjunct treatment of urethral strictures in men. The DCB initially treats the stricture through balloon dilatation and subsequently aims to prevent recurrence via the localized application of Paclitaxel. Our study assesses the safety and efficacy of the DCB in an Australian population with strictures exceeding 2 cm, who have undergone at least two prior procedures for urethral stricture disease. Methods: Patients were prospectively recruited from November 2019 to September 2021. International prostate symptom score (IPSS), IPSS QOL, and voiding parameters were collected at baseline, and again at 1, 6, 12, and 18 months. The DCB was applied by a single consultant urologist under rigid cystoscope with shallow direct vision internal urethrotomy with a cold knife prior to application of the DCB. Results: Seventeen patients were recruited with an average of 7.7 prior urethral procedures for recurrent stricture disease. In total, 76% were stricture free at 30 months follow-up. There were improvements in almost all parameters including max flow, average flow, IPSS, and IPSS QOL scores at 12 and 24 months. There were no complications. Conclusion: The DCB is a safe and effective method at reducing the rates of recurrence for high-risk stricture disease and can delay or prevent the need for urethroplasty in what remains a very challenging cohort of patients.