Urethral stricture is a decrease in urethral caliber. There are different therapeutic options for its treatment, with variable correction rates: mechanical or pneumatic dilation, endoscopic urethrotomy, urethral stents or urethroplasty. Paclitaxel is a drug with antifibrotic and antiproliferative properties used in endovascular procedures to prevent restenosis. The Optilume© balloon coated with this drug combines pneumatic dilation with the intraurethral administration of paclitaxel.
We aim to report the initial experience with Optilume© urethral drug-coated balloon.

We present a series with the first patients treated in our environment with clinically significant penile and bulbar urethral stenosis who underwent pneumatic urethral dilation with Optilume© urethral drug-coated balloon. Surgeries were performed in an outpatient regimen. Before the procedure, patients were studied with urethro-cystography and urpflowmetry, and subjective micturition quality was evaluated with the IPSS questionnaire. During and after the procedure, pain was evaluated with the verbal and analog scale to assess the tolerability of the procedure. Subsequent follow-up was carried out at one week, one month, and three months with the IPSS questionnaire, and a post-procedural uroflowmetry was also performed.

Fifteen patients were treated with Optilume© urethral drug-coated balloon. The average age of the patients was 69 years. The etiologies were varied, and six patients had previously received other stenosis treatments. All patients had non-assessable pre-Optilume© uroflowmetry with improvement in median Qmax at three months. Average length of stenosis was 1.8 cm. Average time per procedure was 45 minutes with good tolerance. Average IPSS improvement was 17.8 points, with all patients presenting mild symptoms three months after treatment.

Urethral stricture is a decrease in urethral caliber. In men, an increase in incidence is observed above 55 years of age. Studies indicate that approximately 0.6% of men suffer urethral stricture in their lifetime. The causes are multiple: chronic infectious or inflammatory processes, trauma or iatrogenic injuries during urethral catheterizations or secondary to prostate surgeries, congenital and idiopathic causes. 
The FDA-approved device Optilume© uses a drug-coated balloon to dilate the urethra at the site of the stricture, combined with the transfer of paclitaxel to the urethral wall, and is theorised to prevent the stricture from recurring (1).
The drug-coated balloon may offer an intermediate step prior to repeated dilations, urethrostomies, or urethroplasty. This treatment modality is a promising alternative to current endoscopic management and an option for patients that are poor surgical candidates or decline urethroplasty (2). Economic evaluations against endoscopic urethrotomy and urethroplasty favour its use in the NHS in England (3).

Pneumatic urethral dilation with Optilume® urethral drug-coated balloon as an outpatient surgery is a minimally invasive, efficient and technically simple technique, with practically no rate of major complications and well tolerated, with a significant improvement in the voiding quality of patients three months after the procedure.

1.	FDA approves the Optilume® urethral drug coated balloon for the treatment of urethral strictures. BJU Int. 2022;129:305-305. https://doi.org/10.1111/bju.15716
2.	VanDyke ME, Morey AF, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Virasoro R, Hagedorn JC, Levin R, DeSouza E, DiMarco D, Erickson BA, Olsson C, Elliott SP. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2023 Dec 18;5(3):366-373. doi: 10.1002/bco2.312. PMID: 38481667; PMCID: PMC10927926.
3.	Kelly L, Shore J, Wright J, Patrick C, Holmes H. Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture. BJUI Compass. 2023 Apr 10;4(4):430-436. doi: 10.1002/bco2.241. PMID: 37334026; PMCID: PMC10268567.