Efficacy and Safety of Optilume; A Drug-Coated Balloon Treatment for Anterior Urethral Stricture

ABSTRACT

Objective: To determine the efficacy and safety of Optilume; a drug-coated balloon (DCB) treatment for anterior urethral strictures.

Methodology: This multi-centered descriptive case series study was carried out in the Department of Urology and Renal Transplant, Sharif Medical City Hospital, Lahore and the Department of Urology, National Hospital & Medical Center, Lahore on thirty cases presenting with ≤3 cm strictures in the anterior urethra. This study was conducted for a duration of thirteen months starting from November 2021 to October 2022. Follow-up was done at two weeks, 3 months, 6 months, and one year. The primary efficacy endpoint was an improvement in International Prostate Symptom Score (IPSS), secondary outcomes included post micturition residual urine (PMRU), maximum urinary flow rate (Qmax), the International Index of Erectile Function (IIEF), and quality of life. The variables were analyzed by computer-based software and descriptive statistics were used to present the outcomes.

Results: A total of 30 patients were treated with Optilume DCB, 13(43%) patients completed one year follow-up and 17(56%) completed 6 months follow-up. Eighteen (60%) patients had a history of endoscopic treatment. There were no treatment-related side effects after one year  of treatment. Success was achieved in 100% at a mean follow-up of 8.4 months and the baseline mean change in IPSS score was 18 at one year. Quality of life, Qmax flow rate, and PMRU improved significantly from the baseline.

Conclusion: One year treatment data shows that Optilume DCB is safe and effective for the treatment of recurrent strictures of the anterior urethra as it showed a significant improvement in the present study.

By Muhammad Rafiq Zaki, et al.

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