Internal urethrotomy versus Optilume™ drug-coated balloon dilatation for the management of anterior urethral strictures: morbidity comparison of the techniques

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INTRODUCTION: Direct visual internal urethrotomy (DVIU) for short anterior urethral strictures is associated with a high rate of stricture recurrence. Optilume™ drug-coated balloon (ODCB) has recently emerged as a minimally invasive treatment alternative. However, comparative data between ODCB and DVIU are limited. This multicenter study aims to compare the two procedures in terms of functional outcomes and stricture-free survival (SFS) in patients with anterior urethral strictures. METHODS: This multicenter retrospective study included 140 patients treated for anterior urethral stricture under 3 cm in length with either ODCB dilatation or internal urethrotomy. Data were collected from five European tertiary referral centers between November 2010 and April 2026. Stricture length was assessed by either cystoscopy, retrograde urethrography, or both. Stricture recurrence during follow-up was defined as symptomatic restenosis requiring reintervention. Multivariable Cox regression analysis was performed to identify predictors of recurrence. SFS was estimated using Kaplan-Meier estimates, with group comparisons assessed using the log-rank test. KEY FINDINGS: A total of 68 (48%) patients underwent DVIU and 72 (52%) ODCB. Prior stricture treatment had been performed in 6 (9%) in the internal urethrotomy group and 56 (78%) in the ODCB group (p < 0.001). Prior dilatations were performed in 6 (9%) patients for DVIU and 27 (38%) for ODCB dilatation (p < 0.001). The groups were otherwise similar with regards to baseline characteristics, including stricture length, diabetes mellitus, stricture site. The median follow-up was 12 months (IQR: 4-29) in the internal urethrotomy group and 9.5 months (IQR: 5-14) in the ODCB group. Postoperative complications were reported in 3% of patients after DVIU and 6% after ODCB dilatation. Median preoperative IPSS was 20.5 (15-26) for DVIU and 18.5 (11-25) for ODCB dilatation (p = 0.4). The median IPSS after three months was 16 (13-20) for DVIU and 6.5 (3-11) for ODCB dilatation (p < 0.001). The type of surgery was not predictive of stricture recurrence at multivariable cox regression analysis. SFS after 12 months was 67% (95% CI: 56-80%) for internal urethrotomy and 68% (95% CI: 50-82%) for Optilume™ (p = 0.81). CONCLUSIONS: Despite being used in a substantially more pretreated cohort, ODCB dilatation showed similar safety and SFS after 12 months as compared to DVIU, suggesting a potential role as an effective salvage strategy after failed endoscopic treatment or even early line treatment. Future prospective studies are needed to better define selection criteria and optimal treatment sequencing.

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