Drug‐Coated Balloon (Optilume ® ) Shows a Low Reintervention Rate in Patients With Bulbar Urethral Strictures: Real‐World Data From Two German Centers

Background Bulbar urethral strictures are a common cause of lower urinary tract symptoms (LUTSs) in men and frequently recur after standard endoscopic treatments. There is growing interest in identifying less invasive techniques that provide durable outcomes compared to conventional endoscopic methods. Optilume has shown favorable outcomes in prospective trials, but real‐world evidence, especially including treatment‐naïve patients, remains limited. Methods We performed a retrospective study in two German urology practices, including 40 men with symptomatic bulbar urethral strictures. Symptoms were assessed using the International Prostate Symptom Score (IPSS) and IPSS‐derived quality‐of‐life (QoL) score at baseline and at follow‐up. The primary endpoints were changes in IPSS and QoL; secondary endpoints included reintervention and safety. Nonparametric paired testing (Wilcoxon) and correlation analysis (Pearson) were applied. Results Median follow‐up was 29.5 months. IPSS improved from a median of 19.5 (2–35) to 6.0 (0–26), and QoL improved from 5.0 (0–6) to 1.0 (0–5) ( p < 0.000001). The median absolute change was ΔIPSS −10.5 overall; ΔIPSS was −16.5 in treatment‐naïve patients and −9.5 in previously treated patients. Median ΔQoL was −4.0 overall (−3.5 treatment‐naïve; −4.0 previously treated). One patient (2.5%) was scheduled for reintervention due to subjective dissatisfaction despite IPSS improvement. Treatment‐naïve patients showed a trend toward better outcomes. Conclusions Optilume demonstrated excellent mid‐term outcomes (median follow‐up: 29.5 months) in the treatment of bulbar urethral strictures, with significant improvements in symptom burden and QoL and a low reintervention rate (2.5%) in a real‐world two‐center cohort with a nonsignificant trend toward greater symptomatic improvement in treatment‐naïve individuals. These findings support Optilume as a viable minimally invasive option. Larger prospective studies incorporating stricture‐specific patient‐reported outcome measures and comparative designs are needed to confirm long‐term effectiveness, cost considerations, and optimal patient selection.