Early Real-World Experience With Optilume Drug-coated Balloon for Anterior Urethral Strictures and Posterior Urethral Stenoses - 04/11/25

Doi : 10.1016/j.urology.2025.10.025

Hiren V. Patel ^a,^⁎ , Bradley A. Erickson ^b, Behzad Abbasi ^c, Nejd F. Alsikafi ^d, Joshua A. Broghammer ^e, Kshitij Pandit ^f, Jill C. Buckley ^f, Sean P. Elliott ^g, Seyedeh Sima Daryabari ^h, Jeremy B. Myers ^h, Thomas G. Smith ⁱ, Grady Lindekugel ^j, Bryan B. Voelzke ^j, Alex J. Vanni ^k, Lee C. Zhao ^l, Benjamin N. Breyer ^c
^a Department of Urology, The Ohio State University Wexner Medical Center, Columbus, OH
^b Department of Urology, University of Iowa, Iowa City, IA
^c Department of Urology, University of California San Francisco, San Francisco, CA
^d Uropartners, Gurnee, IL
^e Department of Urology, University of Kansas, Kansas City, KS
^f Department of Urology, University of San Diego Health System, San Diego, CA
^g Department of Urology, University of Minnesota, Minneapolis, MN
^h Division of Urology, University of Utah, Salt Lake City, UT
ⁱ Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX
^j Spokane Urology, Spokane, WA
^k Department of Urology, Lahey Hospital and Medical Center, Burlington, MA
^l Department of Urology, New York University Langone Medical Center, New York City, NY

^⁎Address correspondence to: Hiren V. Patel, M.D., Ph.D., Department of Urology, The Ohio State University Wexner Medical Center, 915 Olentangy River Road, Suite 3117, Columbus, OH 43212.Department of Urology, The Ohio State University Wexner Medical Center915 Olentangy River Road, Suite 3117ColumbusOH43212

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Tuesday 04 November 2025

ABSTRACT

Objective

To determine the early experience with paclitaxel-drug coated balloon (DCB) for both anterior urethral stricture disease (aUSD) and posterior urethral stenoses (PUS).

Methods

A retrospective review of patients undergoing Optilume DCB in the Trauma and Urologic Reconstructive Network of Surgeons (TURNS) database was performed. Both functional (improved subjective voiding without a secondary procedure) and anatomic (open lumen on cystoscopy) success rates were determined. Kaplan Meier estimates were used to determine the risk of failure by LSE classification and LSE Stage.

Results

A total of 319 patients were treated with the DCB, of which 260 were for aUSD and 59 were for PUS. Median age was 64 years (Interquartile range [IQR] 48-73). Recurrence was noted in 119 patients (37.3%) at a median follow-up of 5.7 months (IQR 3-12). For aUSD, the 1-year functional recurrence-free survival was 78.4% (95% CI 71.8-85.4) and anatomical recurrence-free survival was 66.4% (95% CI 59.5-74.2). For PUS, the 1-year functional recurrence-free survival was 75.8% (95% CI 61.4-93.7) and anatomical recurrence-free survival was 59.4% (95% CI 44.1-80). Recurrences of any kind were significantly more likely in patients with strictures after hypospadias repair (HR 5.21, 95% CI 1.06-25.6, P = .042), and use of 24 Fr, 3 cm DCB (HR 3.64, 95% 1.10-12.09, P = .035). These were also significant predictors of anatomical recurrences.

Conclusion

Multi-institutional utilization of the DCB for aUSD and PUS demonstrates a low effectiveness among high-risk strictures. Recurrence after DCB varies based on stricture characteristics and subtype, which are important for preoperative counseling and postoperative surveillance.

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