Efficacy of the optilume® drug-coated balloon for recurrent urethral stricture after prior urethroplasty: a 12-month multicenter follow-up study.

PURPOSE: Recurrent urethral stricture following urethroplasty remains a clinical challenge. This study aimed to evaluate the efficacy and safety of the Optilume® paclitaxel drug-coated balloon (DCB) in patients with recurrent anterior urethral strictures after prior urethroplasty.

METHODS

This multicentre retrospective study included 25 male patients (mean age 60.6 ± 18.25 years) treated at two German centres between January 2021 and October 2025. The Optilume® DCB (30 Fr, 5 cm) was deployed under cystoscopic guidance and inflated to 10 atm for 7 min. The primary endpoint was functional success, defined as absence of obstructive symptoms and freedom from re-intervention at 12 months. Secondary endpoints included changes in International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QoL), and post-void residual (PVR) urine.

RESULTS

Of the 25 treated patients, 23 had completed 12-month follow-up and were evaluable for the primary endpoint; functional success was achieved in 19 of these 23 patients (83%). Kaplan-Meier analysis demonstrated a 1-year freedom-from-re-intervention rate of 75.4% (95% CI 60.0-94.7%). Mean IPSS improved from 23.6 ± 7.25 to 16.8 ± 9.84 (p = 0.001; Cohen's d = 0.73), while IPSS-QoL improved from 4.6 ± 0.92 to 3.0 ± 1.85 (p < 0.001; Cohen's d = 0.79). PVR showed a non-significant reduction (93.8 to 71.0 mL; p = 0.137). No major complications or cases of urinary incontinence were observed. Median follow-up was 13.4 months (IQR 9.9-20.6).

CONCLUSION

The Optilume® DCB represents an effective and minimally invasive salvage treatment for recurrent anterior urethral stricture after urethroplasty, providing durable functional improvement and low retreatment rates at 12 months.