A drug-coated balloon treatment for urethral stricture: preliminary experience in an Italian real-life cohort.

Background: Urethral stricture is an abnormal narrowing of the urethra and occurs in anterior urethra for 92% of cases. Although open surgery is considered the gold standard for this type of disease, endoscopic procedures are the most commonly used. The Optilume^® Drug Coated Balloon (DCB) (Urotronic, Inc., Plymouth, MN, USA) is the first DCB intended for the treatment of male urethral strictures. Here we report the results of a multicenter Italian real-life study.

Methods: We collected data from nine Italian centers. Patients with urethral strictures or bladder neck stricture were treated with the Optilume^© DCB. We evaluated variation in IPSS, QoL and IIEF5 score, QMax, PVR, and freedom from repeat intervention.

Results: Overall, 130 subjects were treated; median follow-up was six months. Mean age and prostate volume were 64 and 45 mL. Total median operative time was 15 minutes whereas the median time of Optilume application was 7 minutes. IPSS and QoL changed from a mean of 24 and 4 points at baseline to 10 and 1 points respectively at the last follow-up (P<0.001). We have also recorded a significant improvement in Qmax and PVR from 8 mL/s and 100 mL at baseline to 17.8 mL/s and 0 mL at the last follow-up (P<0.001). Intra and post operative not serious complications occurred in 3 and 10 patients, respectively. Six patients underwent reoperation during follow-up.

Conclusions: In our experience, the Optilume^© represents a valid option in the management of patients with urethral stricture, with or without previous surgery.