Drug-coated balloon (DCB) dilatation offers a novel minimally invasive option for recurrent anterior urethral strictures. Optilume™, a paclitaxel-coated DCB, was approved by the FDA in 2021.2 A number of large trials, such as ROBUST I, II, and III have demonstrated durable efficacy with freedom from repeat intervention above 70%.3,4
We sought to assess real-world utilisation patterns of DCBs. In our international survey of 102 DCB users, we found that uptake has been broad among reconstructive specialists and generalists. However, standardization of usage and technique is lacking. Many urologists appear to be offering DCB in broader and often off-label settings, including penile strictures, primary treatment, posterior stenosis, and post-urethroplasty recurrence.
A post-hoc multivariable analysis was informative in this regard. Higher-volume users were more likely to deploy the device using flexible cystoscopy and to indicate it for bladder neck stenosis and recurrent strictures. This suggests that growing familiarity with DCB is associated with broader clinical application rather than just procedural efficiency.
Reconstructive urologists, by contrast, were less likely to offer DCB for primary treatment or penile strictures, implying a more selective adoption pattern in clinicians most familiar with urethroplasty as the reference standard. Many respondents framed DCB as a useful alternative for selected patients, particularly those who are poor candidates for urethroplasty or who wish to avoid reconstruction. This variation in practice reflects a field in early transition: clinicians are enthusiastic, increasingly willing to use DCB outside trial-defined indications, and making pragmatic decisions in areas where evidence is lacking.
This is the key message of our study: DCB is not being used simply in its narrowly defined salvage option for recurrent anterior strictures. It is being integrated as a minimally invasive option, often in areas where evidence remains limited and where formal guidance has not yet caught up with real-world use. Upcoming trials will seek to address the question of DCB efficacy outside its current recommended usage. These include FIRST CARE (treatment-naïve patients), BALDIKA (one prior DVIU), RUSTIC (DCB vs non-drug-coated), and ENDURE-1 (ureteric stricture).5–8
Taken together, these findings suggest that DCB has entered a phase of rapid clinical diffusion in which adoption is outpacing standardization. The next priority is not simply more data on efficacy, but rigorously comparing its outcomes with the standard of care. This information would allow a better definition of where DCB belongs in the treatment algorithm, how it should be performed, and what counselling should accompany its use in everyday practice.
Written by: Diarmuid D Sugrue,1,2 Felix Campos-Juanatey,3 Elaine J. Redmond1,4
On behalf of the Trauma and Reconstructive Urology Working Party of the European Association of Urology Young Academic Urologists
- Department of Urology, Cork University Hospital, Cork, Ireland
- Royal College of Surgeons in Ireland, Strategic Academic Recruitment (StAR) Programme, Dublin, Ireland
- School of Medicine, Unit of Andrology and Reconstructive Urology, IDIVAL, Marqués de Valdecilla University Hospital, Cantabria University, Santander, Spain
- School of Medicine, University College Cork, Cork, Ireland
- Alwaal A, Blaschko S, McAninch J, Breyer B. Epidemiology of urethral strictures. Transl Androl Urol 2014;3:20913–20213.
- FDA approves the Optilume® urethral drug-coated balloon for the treatment of urethral strictures. BJU Int 2022;129:305–305.
- Srikanth P, DeLong J, Virasoro R, Elliott SP. A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST III Study. J Endourol 2025.
- DeLong J, Virasoro R, Pichardo M, Estrella R, Lay RR, Espino G, et al. Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study. J Urol 2025;213:90–8.
- Mahdi MB, Haase RN, Sander L, Tuckus G, Liltorp DL, Jørgensen L, et al. Treatment of bulbar urethral strictures with Optilume drug-coated balloons in a previously untreated population (FIRST-CARE): protocol for a single-blind multicentre randomised controlled trial. BMJ Open 2026;16:e103948.
- Frank König. Drug-coated balloon dilatation catheter for transurethral treatment of urethral strictures. German Clinical Trials Register 2025.
- Henrik Kjölhede. NCT06795074 - Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon. ClinicalTrialsGov 2025.
- Landman J. NCT07020520 | EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures. ClinicalTrialsGov 2025.