Drug-Coated Balloon Therapy (Optilume)
The Optilume® paclitaxel-coated balloon has randomized evidence in recurrent anterior urethral strictures, predominantly bulbar, from ROBUST III.[10] Ureteral paclitaxel-coated-balloon use remains off-label and investigational: a 25-patient series used Lutonix, and a six-patient series used Optilume with median six-month follow-up.[1][2][3][8]
The canonical WARWIKI page lives in the cross-cutting Treatment Atlas: Drug-Coated Balloon Therapy.
For related urethral options, see DVIU and Urethral Dilation and Endoscopic Urethroplasty (Suturing Device). For the ureteral endoscopic counterpart, see Endoureterotomy.
Urethral Selection Snapshot
| Best supported | Less certain / off-label |
|---|---|
| Recurrent bulbar stricture less than 3 cm after prior dilation or DVIU. AUA: surgeons may offer DCB with dilation or DVIU . EAU: offer DCB after at least two prior endoscopic treatments in patients not fit or unwilling for urethroplasty .[1][2] | Penile strictures of 3 cm or less are within the US anterior-urethral indication, but outside the AUA's bulbar-only recommendation; the ROBUST III penile subgroup was too small for a separate efficacy assessment.[1][4] |
| A patient with recurrent bulbar stricture elects DCB after counseling on urethroplasty; AUA recommends offering urethroplasty after failed dilation or DVIU .[1] | Posterior urethral stenosis, BNC, or VUAS |
| Patient understands that durability has not been compared directly with urethroplasty | Treatment-naive strictures and patients with lichen sclerosus, prior anterior urethroplasty, or prior hypospadias repair (outside ROBUST III).[4] |
Technique Snapshot
The operative concept is mechanical dilation plus local paclitaxel delivery. The working sequence is as follows. Use retrograde urethrography or voiding cystourethrography to define stricture location, length, and lumen caliber for balloon sizing, as recommended in the US device instructions; then confirm the lesion endoscopically and obtain wire access.[4] All 79 ROBUST III DCB recipients underwent pre-dilation with an uncoated balloon or DVIU to at least 20 Fr before coated-balloon placement; the US device instructions do not require a separate pre-dilation step.[2][4][5] Handle the catheter with dry sterile gloves or dry gauze, minimizing contact with the coating; do not wipe or immerse the balloon with fluid before insertion, and replace the device if the balloon contacts fluid before use.[4] Select a balloon whose coated segment extends approximately 0.5 to 1 cm beyond each end of the stricture. For bulbar strictures, size the diameter slightly larger than the healthy distal urethra but no more than 30% larger; for penile strictures, match the healthy distal diameter and avoid 36 Fr.[4] Center the balloon, leave it uninflated for at least one minute to hydrate, and then inflate according to the device instructions.[4] Leave a 12 to 14 Fr Foley catheter in place for at least two days or longer per standard care.[4] Follow with symptom score, uroflow and PVR, and cystoscopy when recurrence is suspected. ROBUST III enrolled anterior strictures of 3 cm or less (about 90% bulbar) after at least two prior endoscopic treatments, including dilation or DVIU; six-month stricture-free success (passage of a 16 Fr flexible cystoscope or 14 Fr catheter, with earlier target-stricture retreatment counted as failure) was 50/67 (74.6%) with DCB versus 11/41 (26.8%) with standard dilation or DVIU in the complete-case analysis.[2][4] At two years, Kaplan–Meier freedom from repeat intervention was 77.8% in the DCB arm versus 23.6% at the control arm's one-year cutoff (p < 0.001); most controls crossed over after six months.[5] At three years, freedom from repeat intervention was 71.9% in the original DCB arm, without a concurrent control group.[9] Ontario Health's technology assessment notes that this estimate may be inflated, because participants whose treatment failed without a repeat procedure were censored.[11] ROBUST I, a separate single-arm cohort of 53 men with recurrent bulbar strictures ≤2 cm and 1 to 4 prior endoscopic interventions, had 43 evaluable at 3 years (33 visit completers plus 10 earlier clinical failures); functional success (at least 50% IPSS reduction without retreatment) was 29/43 (67%), and freedom from retreatment was 33/43 (77%).[6] At 5 years, 31 men had completed all follow-up; functional success was 25/43 (58%), and Kaplan-Meier freedom from repeat intervention was 71.7%.[6][7] The label calls for at least 1 minute of coating hydration before inflation, at least 5 minutes of inflation at the rated burst pressure without exceeding it, and a 12 to 14 Fr Foley catheter for at least 2 days; it highly recommends an inflation device with a pressure gauge.[4]
Counseling Snapshot
Drug-coated balloon therapy is an endoscopic option for selected recurrent bulbar strictures with better patency than standard dilation or DVIU in ROBUST III. In ROBUST III, adjudicated device- or procedure-related postprocedural hematuria occurred in 9/79 DCB recipients versus 0/48 controls, dysuria in 5/79 versus 0/48, and UTI in 5/79 versus 1/48.[4] Paclitaxel was detected in semen. The US label calls for abstinence or condom use for 30 days to limit partner exposure; men with partners of child-bearing potential should use highly effective contraception and avoid fathering children for at least six months.[4] The label contraindicates hypersensitivity to paclitaxel or structurally related compounds and urologic implants (such as a penile prosthesis or artificial urinary sphincter), and requires resolution of an active urinary tract infection before treatment.[4] AUA does not recommend repeat DCB use; its efficacy has not been ascertained.[1][2][4] The US label warns that multiple treatments of the same stricture increase paclitaxel exposure and that the associated risks are unknown.[4] A DCB failure should trigger reassessment of stricture length, spongiofibrosis, radiation history, lichen sclerosus, and candidacy for definitive reconstruction rather than automatic serial repeat dilation.
Videos
References
1. Wessells H, Morey A, Souter L, Rahimi L, Vanni A. Urethral stricture disease guideline amendment (2023). J Urol. 2023;210(1):64-71. doi:10.1097/JU.0000000000003482.
2. EAU Guidelines on Urethral Strictures: limited update 2026, section 6.2.3.d, drug-coated balloon dilatation. https://uroweb.org/guidelines/urethral-strictures. Accessed September 26, 2026.
3. Kallidonis P, Spiliopoulos S, Papadimatos P, et al. Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures. World J Urol. 2022;40(5):1231-1238. doi:10.1007/s00345-022-03952-1.
4. Urotronic. Optilume Urethral Drug Coated Balloon Catheter: Instructions for Use, 1111-003 Rev B (US). Checked September 26, 2026.
5. VanDyke ME, Morey AF, Coutinho K, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2024;5(3):366-373. doi:10.1002/bco2.312
6. Virasoro R, DeLong JM, Estrella RE, et al. A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study. Res Rep Urol. 2022;14:177-183. doi:10.2147/RRU.S359872
7. DeLong J, Virasoro R, Pichardo M, 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(1):90-98. doi:10.1097/JU.0000000000004229
8. Zorzi F, Scilipoti P, Alanazi A, et al. "Paclitaxel Drug-coated Balloon (Optilume) for Ureteral Stricture Management: Technical Description and Initial Clinical Experience." Eur Urol Focus. Published online June 13, 2026. doi:10.1016/j.euf.2026.05.004.
9. 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;39(9):968-974. doi:10.1089/end.2024.0718.
10. Elliott SP, Coutinho K, Robertson KJ, et al. "One-year results for the ROBUST III randomized controlled trial evaluating the Optilume drug-coated balloon for anterior urethral strictures." J Urol. 2022;207(4):866-875. doi:10.1097/JU.0000000000002346
11. Ontario Health (Quality). "Paclitaxel-Coated Balloon Dilation for Adults With Recurrent Bulbar Urethral Stricture: A Health Technology Assessment." Ont Health Technol Assess Ser. 2026;26(4):1–160. PMID:42311576.