Citation
Patel HV, Ericksonb BA, Abbasi B, Alsikafi NF, Broghammer JA, Pandit K, Buckley JC, Elliott SP, Daryabari SS, Myers JB, Smith TG 3rd, Lindekugel G, Voelzke BB, Vanni AJ, Zhao LC, Breyer BN. Early real-world experience with Optilume® drug-coated balloon for anterior urethral strictures and posterior urethral stenoses. Urology. 2025 Oct 16:S0090-4295(25)01012-X. doi: 10.1016/j.urology.2025.10.025. Epub ahead of print. PMID: 41109561.
Abstract
To determine the early experience with paclitaxel-drug coated balloon (DCB) for both anterior urethral stricture disease (aUSD) and posterior urethral stenoses (PUS). 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. 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. 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.
Key Points
- Published in Urology in 2025.
- Indexed in PubMed as PMID 41109561.
- Mapped to Urethral Stricture & Urethroplasty, Prosthetics (AUS/IPP), Trauma & Fistula.
- Abstract available from PubMed and rendered as static text on this page.
Clinical Relevance
This article contributes to the urethral stricture and urethroplasty literature, with emphasis on staging, reconstruction, definitions of success, and long-term functional outcomes.