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.
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.
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).
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.
World journal of urology. 2026 Jun 04*** epublish ***
Georgi Tosev, Cornelius Geil-Bierschenk, Ivan Damgov, Franklin E Kuehhas, Johannes Salem, Johannes Huber, Fabian Falkenbach, Philipp Reimold, Timur H Kuru
Mannheim Urology, Urology Practice, Seckenheimer Hauptstrasse 143, 68239, Mannheim, Germany. ., Mannheim Urology, Urology Practice, Seckenheimer Hauptstrasse 143, 68239, Mannheim, Germany., Division of Pediatric Nephrology, Center for Pediatric and Adolescent Medicine, University of Heidelberg, Heidelberg, Germany., Kuehhas Andrology, Tulpengasse 2/2, 1080, Vienna, Austria., Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, 14770, Brandenburg an Der Havel, Germany., Department of Urology, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.