Drug-Coated Balloon Therapy
Drug-coated balloon (DCB) therapy combines mechanical dilation with local delivery of an antiproliferative drug, usually paclitaxel, to reduce fibroblast proliferation and scar recurrence after dilation. In reconstructive urology, the concept is mature enough for FDA-approved urethral use with Optilume but remains investigational and off-label in the ureter.[1][2][3][4]
This page is the cross-anatomic surgical technique page for DCB use in urethral and ureteral strictures. For the pharmacology/device deep-dive, see Drug-Coated Balloon Therapy (Optilume). For related endoscopic procedures, see DVIU and Urethral Dilation and Endoureterotomy.
Regulatory Position
The most important practical distinction is that Optilume is not a ureteral device.
| Site | Device / Evidence | Current Status |
|---|---|---|
| Recurrent anterior urethral stricture | Optilume urethral DCB; ROBUST I and ROBUST III program | FDA-approved for anterior urethral strictures; AUA guideline recommendation is narrower: recurrent bulbar strictures <3 cm after prior dilation or DVIU[1][4] |
| BPH / prostatic urethra | Optilume BPH catheter system; PINNACLE and related studies | FDA-approved for LUTS secondary to BPH in selected prostate sizes[5][6] |
| Ureteral stricture | Lutonix paclitaxel-coated balloon pilot data; preclinical ureteral paclitaxel work | Off-label and investigational; no published clinical series specifically using Optilume in the ureter[7][8][9] |
The phrase "Optilume for ureteral stricture" should therefore be avoided unless discussing a formal investigational protocol or an explicitly off-label adaptation. The more accurate concept is paclitaxel-coated balloon therapy for ureteral stricture, with the only published clinical ureteral series using Lutonix, not Optilume.[7]
Mechanism
DCB therapy has two linked effects:
- Mechanical dilation immediately opens the narrowed lumen.
- Local paclitaxel delivery inhibits the proliferative wound-healing response that normally follows dilation.
Paclitaxel stabilizes microtubules and arrests dividing cells, which reduces smooth-muscle cell proliferation, fibroblast activation, migration, collagen deposition, and extracellular matrix formation at low local concentrations.[8][10][11][12]
Ureteral Wall Penetration
The ureteral urothelium is a strong barrier, but porcine work by Liourdi et al. showed paclitaxel delivery after drug-eluting balloon inflation into the urothelium, submucosa, and muscle layers by 12-24 hours, with less inflammation than conventional balloon controls.[9] That finding is the key preclinical bridge that makes ureteral DCB therapy biologically plausible.
Urethral Technique
In urethral stricture disease, Optilume is generally used after guidewire access and endoscopic confirmation of a short recurrent stricture.
| Step | Practical Point |
|---|---|
| Cystoscopy / urethroscopy | Confirm location, length, caliber, and suitability |
| Pre-dilation | Dilate the stricture enough to pass and deploy the DCB safely |
| DCB placement | Center the coated segment across the strictured area |
| Inflation | Inflate per device instructions / trial protocol, commonly several minutes at target pressure |
| Catheter | Small Foley catheter for short-term drainage; avoid unnecessary manipulation of the treated surface |
| Follow-up | Symptom score, uroflow, PVR, and cystoscopy when recurrence is suspected |
Urethral Patient Selection
| Best Supported | Less Certain / Off-Label |
|---|---|
| Recurrent bulbar stricture <3 cm after prior dilation or DVIU | Penile urethral strictures |
| Patients seeking a less invasive bridge before urethroplasty | Posterior urethral stenosis, bladder-neck stenosis, VUAS |
| Patients counseled that DCB is not equivalent to urethroplasty durability | Treatment-naive strictures pending FIRST-CARE results |
| Patients able to comply with follow-up and contraception counseling | Repeat DCB after DCB failure |
The AUA guideline amendment specifically narrows its recommendation to recurrent bulbar urethral strictures <3 cm, despite the broader anterior-urethral FDA label, because ROBUST III was not powered for penile strictures.[4]
Urethral Evidence
| Study | Design | Population | Key Result |
|---|---|---|---|
| ROBUST I | Prospective single-arm | Recurrent bulbar strictures <=2 cm | 5-year freedom from reintervention 71.7%; Qmax improved from 5.0 to 19.9 mL/s[13] |
| ROBUST III | Randomized controlled trial | Recurrent anterior strictures <=3 cm with prior endoscopic treatment | 6-month anatomical success 75% vs 27%; 1-year freedom from reintervention 83.2% vs 21.7%[1] |
| ROBUST III 3-year | Extension | Same DCB cohort | 71% freedom from reintervention at 3 years[14] |
| TURNS real-world cohort | Multicenter retrospective | Anterior strictures and posterior stenoses | More modest early results than ROBUST; posterior use remains off-label[15] |
The clinical message is not "DCB replaces urethroplasty." It is that DCB is a better endoscopic option than repeat dilation/DVIU for carefully selected recurrent bulbar strictures, especially when the patient wants to delay or avoid formal reconstruction.
Ureteral Technique Concept
For ureteral strictures, DCB therapy is extrapolated from balloon dilation and endoureterotomy. Published ureteral DCB work uses the Lutonix paclitaxel-coated balloon, not Optilume.[7]
The reported ureteral workflow is:
- define the stricture with retrograde or antegrade pyelography,
- obtain safe guidewire access across the stricture,
- predilate with a high-pressure balloon,
- inflate a ureter-caliber paclitaxel-coated balloon across the lesion for several minutes,
- repeat dilation if needed,
- stent or drain according to local protocol,
- monitor with imaging and renal function follow-up.
Ureteral Fit
| Potential Fit | Why It Is Still Investigational |
|---|---|
| Short benign ureteral strictures | Only one small clinical series; not Optilume-specific |
| Ureteroenteric anastomotic strictures | Included in the pilot experience, but heterogeneous and recurrence-prone |
| Patients who are poor candidates for reconstruction | DCB may be attractive because morbidity is low |
| Adjunct after endoureterotomy or dilation | Antifibrotic logic is appealing, but clinical protocols are not standardized |
Ureteral DCB therapy should not be framed as equivalent to ureteroureterostomy, ureteral reimplantation, BMG ureteroplasty, or other reconstructive options. It is an emerging endoscopic strategy with limited data.
Ureteral Evidence
Kallidonis et al. 2022
The only published clinical ureteral DCB series is a prospective off-label single-arm pilot study using Lutonix, not Optilume.[7]
| Parameter | Result |
|---|---|
| Device | Lutonix paclitaxel-coated balloon |
| Patients | 25 |
| Etiologies / sites | Ureteroenteric, lower ureteric, upper ureteric, and ureterovesical strictures |
| Mean stricture length | 40 +/- 28.5 mm |
| Mean follow-up | 36 +/- 10.5 months |
| Technique | Predilation with high-pressure balloon, DCB inflation for 4 minutes, repeat up to 3 times if needed |
| 1-year radiologic success | 88% |
| Single DCB-session success | 56% |
| Additional dilation | 32% |
| Failure at 1 year | 12% |
| Complications | One febrile UTI / pyelonephritis; no major device-specific safety signal |
The 88% 1-year success signal is promising, especially compared with the roughly 54% long-term success reported for conventional balloon dilation in meta-analysis, but the data are small, single-arm, off-label, and device-specific to Lutonix.[7][16]
Preclinical Ureteral Paclitaxel Work
| Platform | Model | Finding |
|---|---|---|
| Paclitaxel and ureteral smooth-muscle cells | In vitro | Paclitaxel inhibited proliferation and type III collagen production without cytotoxicity at tested concentrations[8] |
| Paclitaxel-eluting balloon | Porcine ureter | Drug reached submucosa and muscle layers; inflammation was reduced compared with controls[9] |
| Paclitaxel-eluting metal stents | Pig ureter | Bare metal stents occluded frequently; paclitaxel-eluting stents had less hyperplasia and no occlusions in that model[17] |
| Paclitaxel-coated polyurethane stents | Rat ureteroureterostomy | Reduced urothelial hyperplastic proliferation compared with uncoated stents[18] |
| Rapamycin / paclitaxel biodegradable stents | Preclinical biomaterials | Sustained release and reduced proliferative / collagen responses in early models[19] |
Comparison With Other Endoscopic Options
| Approach | Mechanism | Typical Role | Limitation |
|---|---|---|---|
| Plain balloon dilation | Mechanical stretch / fracture | Low-morbidity initial treatment for selected short strictures | High recurrence; no antifibrotic effect[16] |
| DVIU / endoureterotomy | Full-thickness incision and stenting | Better controlled release of scar than dilation alone | Still recurrence-prone; selection sensitive |
| DCB dilation | Mechanical dilation plus local paclitaxel | Evidence-supported in recurrent bulbar urethral stricture; investigational in ureter | Device/site evidence mismatch; cost; uncertain repeat-use strategy |
| Steroid injection adjunct | Anti-inflammatory / antifibrotic injection | Selected urethral, bladder-neck, and ureteroenteric protocols | Variable technique and durability |
| Metallic ureteral stent | Chronic internal scaffold | Ureteral salvage / poor reconstructive candidate | Encrustation, migration, surveillance burden |
| Reconstruction | Excision, graft, flap, or substitution | Best durability for complex strictures | More invasive |
Counseling Points
- DCB therapy is not a generic cure for stricture disease; it is an improved endoscopic strategy for selected settings.
- For the urethra, Optilume has RCT and long-term data, but guideline-supported use is still mainly recurrent bulbar strictures <3 cm.
- For the ureter, published clinical DCB evidence uses Lutonix, not Optilume, and remains off-label.
- Ureteral Optilume claims should be treated cautiously: no published ureteral Optilume outcomes currently establish routine clinical use.
- A DCB failure should trigger reassessment of anatomy and candidacy for definitive reconstruction rather than automatic serial repeat dilation.
- Paclitaxel exposure, contraception guidance, and off-label use should be part of informed consent.
Summary
Drug-coated balloon therapy is a promising antifibrotic extension of endoscopic stricture treatment. In the urethra, Optilume is an FDA-approved, evidence-supported option for recurrent anterior strictures, with the strongest guideline footing in recurrent bulbar strictures <3 cm. In the ureter, the DCB concept is biologically plausible and supported by a small Lutonix pilot series plus preclinical paclitaxel data, but Optilume itself has no published ureteral clinical outcomes and is not FDA-approved for ureteral use. The safest framing is therefore: DCB is established for selected urethral strictures, investigational for ureteral strictures, and never a substitute for durable reconstruction when anatomy demands it.
References
- 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.
- Kapriniotis K, Loufopoulos I, Apostolopoulou A, Anderson PCB, Papaefstathiou E. Drug-coated balloon treatment for urethral strictures: is this the future? A review of the current literature. J Clin Med. 2025;14(8):2854. doi:10.3390/jcm14082854.
- Gauhar V, Yuen SKK, Gadzhiev N, et al. Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? An EAU Endourology scoping review. BMC Urol. 2025;25(1):196. doi:10.1186/s12894-025-01896-3.
- 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.
- Kaplan SA, Moss J, Freedman S, et al. The PINNACLE Study: a double-blind, randomized, sham-controlled study evaluating the Optilume BPH catheter system for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2023;210(3):500-509. doi:10.1097/JU.0000000000003568.
- Saffarzadeh M, Derigs M, Ren R, et al. Device profile of Optilume BPH catheter system for minimally invasive treatment of benign prostatic hyperplasia. Expert Rev Med Devices. 2025. doi:10.1080/17434440.2025.2553051.
- 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.
- Will TA, Polcari AJ, Garcia JG, et al. Paclitaxel inhibits ureteral smooth muscle cell proliferation and collagen production in the absence of cell toxicity. J Urol. 2011;185(1):335-340. doi:10.1016/j.juro.2010.09.006.
- Liourdi D, Kallidonis P, Kyriazis I, et al. Evaluation of the distribution of paclitaxel by immunohistochemistry and nuclear magnetic resonance spectroscopy after the application of a drug-eluting balloon in the porcine ureter. J Endourol. 2015;29(5):580-589. doi:10.1089/end.2014.0683.
- Zhang L, Xu X, Yang R, et al. Paclitaxel attenuates renal interstitial fibroblast activation and interstitial fibrosis by inhibiting STAT3 signaling. Drug Des Devel Ther. 2015;9:2139-2148. doi:10.2147/DDDT.S81390.
- Jung ES, Lee J, Heo NJ, et al. Low-dose paclitaxel ameliorates renal fibrosis by suppressing transforming growth factor-beta1-induced plasminogen activator inhibitor-1 signaling. Nephrology (Carlton). 2016;21(7):574-582. doi:10.1111/nep.12747.
- Wiskirchen J, Schober W, Schart N, et al. The effects of paclitaxel on the three phases of restenosis: smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004;39(9):565-571. doi:10.1097/01.rli.0000133815.22434.55.
- 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.
- 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. doi:10.1089/end.2024.0718.
- Patel HV, Erickson BA, Abbasi B, et al. Early real-world experience with Optilume drug-coated balloon for anterior urethral strictures and posterior urethral stenoses. Urology. 2025. doi:10.1016/j.urology.2025.10.025.
- Lu C, Zhang W, Peng Y, et al. Endoscopic balloon dilatation in the treatment of benign ureteral strictures: a meta-analysis and systematic review. J Endourol. 2019;33(4):255-262. doi:10.1089/end.2018.0797.
- Liatsikos EN, Karnabatidis D, Kagadis GC, et al. Application of paclitaxel-eluting metal mesh stents within the pig ureter: an experimental study. Eur Urol. 2007;51(1):217-223. doi:10.1016/j.eururo.2006.05.054.
- Kram W, Rebl H, Wyrwa R, et al. Paclitaxel-coated stents to prevent hyperplastic proliferation of ureteral tissue: from in vitro to in vivo. Urolithiasis. 2020;48(1):47-56. doi:10.1007/s00240-018-1081-7.
- Duan L, Li L, Zhao Z, et al. Antistricture ureteral stents with a braided composite structure and surface modification with antistenosis drugs. ACS Biomater Sci Eng. 2024;10(1):607-619. doi:10.1021/acsbiomaterials.3c00781.