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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. Optilume is FDA-approved for symptomatic anterior urethral strictures of 3 cm or less in adult men. Use in the ureter is investigational and off-label.[1][2][3][4][26]

For the pharmacology/device deep-dive, see Drug-Coated Balloon Therapy (Optilume). For related endoscopic procedures, see DVIU and Urethral Dilation and Endoureterotomy.

The Optilume BPH catheter system has its own page. It uses the same paclitaxel-coated-balloon platform but is a distinct device for LUTS secondary to BPH, dilating the prostatic urethra (PINNACLE, EVEREST-I, SUMMIT). For that device and its evidence base, see Optilume BPH — Drug-Coated Balloon.

Regulatory Position​

Optilume is not FDA-approved for the ureter.

SiteDevice / EvidenceCurrent Status
Recurrent anterior urethral strictureOptilume urethral DCB; ROBUST I and ROBUST III programFDA-approved for adult men with symptomatic anterior urethral strictures of 3 cm or less; the AUA recommendation is narrower: recurrent bulbar strictures <3 cm, with dilation or DVIU[1][4][26]
BPH / prostatic urethraOptilume BPH catheter system; PINNACLE and related studiesFDA-approved for obstructive LUTS associated with BPH in men aged 50 or older[29]; PINNACLE enrolled men with prostates of 20–80 g[5][6]
Ureteral strictureLutonix paclitaxel-coated balloon pilot data; a 6-patient Optilume series; preclinical ureteral paclitaxel workOff-label and investigational; published clinical experience is limited to small series and case reports[7][8][9][23][24]

"Optilume for ureteral stricture" therefore describes an investigational, off-label adaptation. The largest published clinical ureteral series (25 patients) used the Lutonix paclitaxel-coated balloon.[7] A 2026 single-center report of 6 patients used Optilume.[23] A 2026 EAU Endourology systematic review found 4 clinical reports or series (58 cases) of paclitaxel-coated balloons in the ureter.[24]

Mechanism​

DCB therapy has two linked effects:

  1. Mechanical dilation immediately opens the narrowed lumen.
  2. Local paclitaxel delivery inhibits the proliferative wound-healing response that normally follows dilation.

Paclitaxel stabilizes microtubules and arrests dividing cells.[8][10][11][12] It inhibited ureteral smooth-muscle proliferation and type III collagen production in canine cell culture; evidence on fibroblast activation, migration and matrix deposition comes from renal or vascular models.[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] This preclinical finding supports the biological plausibility of ureteral DCB therapy.

Urethral Technique​

In urethral stricture disease, Optilume is used after guidewire access and endoscopic confirmation of a short recurrent stricture.

StepPractical Point
ImagingRetrograde urethrogram or voiding cystourethrogram is recommended to define stricture location, length and lumen caliber[26]
Cystoscopy and wireCystoscopy, then a 0.038-inch or smaller guidewire across the stricture; the 18 to 30 Fr balloons pass through a flexible cystoscope, and the 36 Fr balloon is placed side by side with the cystoscope[26]
Balloon selectionBalloon length is 0.5 to 1 cm longer than the stricture on each side. In the bulbar urethra, diameter is slightly larger than the distal healthy urethra and not more than 30% larger; in the penile urethra, diameter matches the distal healthy urethra, and the manufacturer does not recommend the 36 Fr balloon there.[26] In nonrandomized ROBUST I subgroups, five-year functional success was 17/22 with 30 Fr versus 8/21 with 24 Fr; the EAU suggests 30 Fr where IFU sizing permits.[13][25]
HandlingThe coated balloon is handled with dry gloves or gauze, is not wiped or immersed, and is never inflated outside the body or before it reaches the stricture; a balloon whose coating contacts fluid before insertion is replaced[26]
Balloon preparationWith the protector on, half-fill the inflation device with sterile saline and aspirate balloon air until no bubbles remain; use a 1:1 saline-contrast mixture when fluoroscopy is planned[26]
Placement and hydrationCenter the coated segment across the stricture and leave it uninflated for at least 1 minute so the coating hydrates[26]
InflationInflate to the rated burst pressure with a gauge-equipped device and hold for at least 5 minutes; do not exceed the rated burst pressure (12 atm for 18 and 24 Fr, 10 atm for 30 Fr, 8 atm for 36 Fr). If the balloon fails before inflation or below the rated burst pressure it is replaced; if it fails after reaching the rated burst pressure, the device is not replaced or repeated[26]
Catheter12 to 14 Fr Foley catheter for at least 2 days or per standard of care, whichever is longer[26]
Follow-upSymptom score, uroflow, PVR, and cystoscopy when recurrence is suspected

The instructions for use do not describe a separate pre-dilation step.[1][26] In ROBUST III, every DCB-arm stricture was predilated to at least 20 Fr with an uncoated balloon, DVIU, or both.[1][26] See the pharmacology page.

Urethral Patient Selection​

Best SupportedLess Certain / Off-Label
Recurrent bulbar stricture <3 cm after prior dilation or DVIUPenile anterior strictures ≤3 cm are on-label in adult men but outside the narrower AUA bulbar recommendation.[4][26]
Patients preferring to defer urethroplasty after counseling that DCB effects on later reconstruction are unknown[1]Posterior urethral stenosis, bladder-neck stenosis, VUAS
Patients counseled that DCB is not equivalent to urethroplasty durabilityTreatment-naive anterior strictures ≤3 cm in adult men are on-label, but first-line efficacy was not tested in ROBUST III; the published FIRST-CARE protocol addresses previously untreated bulbar strictures.[1][26][30]
Patients able to comply with follow-up and contraception counselingRepeat DCB after DCB failure (AUA 2023 does not recommend repeated use)[4]

The AUA 2023 amendment 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. It states that repeated use of the balloon has not been ascertained and is not recommended.[4] EAU 2026 recommends DCB dilatation for a short (<3 cm) bulbar stricture recurring after at least two prior endoscopic treatments in patients not fit or unwilling to undergo urethroplasty , and advises collecting data for other indications within a trial or registry.[25]

Urethral Evidence​

StudyDesignPopulationKey Result
ROBUST IProspective single-arm, 53 menRecurrent bulbar strictures <=2 cm5-year freedom from reintervention 71.7% (Kaplan-Meier; 31 completed all follow-up); functional success (IPSS improvement ≥50% without retreatment) 58% (25/43); Qmax improved from 5.0 to 19.9 mL/s in the as-observed analysis (28 had Qmax measured at 5 years)[13]
ROBUST IIIRandomized, single-blind trial, 127 men (79 DCB, 48 control), 22 sitesRecurrent anterior strictures <=3 cm with at least 2 prior endoscopic treatments (dilation or DVIU) (about 90% bulbar); lichen sclerosus, prior urethroplasty or hypospadias repair, and urethral implants excludedPrimary endpoint (passage of a 16 Fr flexible cystoscope or 14 Fr catheter at 6 months, with earlier reintervention counted as failure) 74.6% (50/67) vs 26.8% (11/41) in the complete-case analysis; ITT difference 44.4% (95% CI 27.6 to 61.1). Between-arm difference in Qmax change from baseline to 6 months (ITT, multiple imputation) +4.78 mL/s. 1-year freedom from repeat intervention (Kaplan-Meier) 83.2% vs 21.7%. The secondary 12-month responder endpoint in the DCB arm (IPSS improvement ≥50%; ITT, multiple imputation; N=79) did not meet its 50% performance goal (59.6%, lower 90% bound 49.9%, p = 0.051)[1][26]
ROBUST III 3-yearExtensionDCB arm71% freedom from reintervention at 3 years; results for the crossover cohort resembled the original DCB arm[14]
TURNS real-world cohortMulticenter retrospective, 319 analyzed patients (260 anterior, 59 posterior; those without follow-up data or managed with intermittent catheterization were excluded from an initially identified 397)Anterior strictures and posterior stenosesMedian follow-up 5.7 months. One-year functional recurrence-free survival 78.4% (anterior) and 75.8% (posterior); anatomical 66.4% and 59.4%. Recurrence was more likely after hypospadias repair and with the 24 Fr, 3 cm balloon. Posterior use is off-label[15]

In ROBUST III, DCB outperformed repeat dilation or DVIU in selected recurrent short strictures. It is an option for patients who want to delay or avoid formal reconstruction.

Female Urethral Stricture — Limited and Low-Quality Evidence​

The Optilume label, the ROBUST trials, and the AUA recommendation are all male. Female DCB evidence remains limited: two single-patient case reports, the 12-patient cohort detailed below, and a separate nine-patient multicenter retrospective series. The latter reported 8/9 free from reintervention at a mean 11 months; comparative efficacy and long-term sphincter safety remain unknown.[20][21][22][27] See Female DVIU and Urethral Dilation for the broader female endoscopic-management context.

ReportDesignnStrictureResult
Stuehmeier 2021[20]Case report1Complex 1.8-cm fibrotic sphincteric stricture, 50-yoQmax 26 mL/s, no PVR, continent at 6 mo. First female DCB report.
Jelisejevas 2025 (conference abstract: 12 treated through October 2024, 10 analyzed; published series: 14 treated through May 2024, 12 analyzed)[21][28]Single-center retrospective12 analyzed (14 treated; 2 excluded)Mean 4.3 prior interventions (range 0–40); ages 31–81At mean 12 months (range 6–41), 11/12 (91.7%) were free from recurrence and repeat intervention; no de novo incontinence was reported; preexisting overflow incontinence resolved in one woman and urge incontinence improved in another. The earlier abstract emphasized longer self-dilation intervals and did not report Qmax or PROs; the published series was uncontrolled.
Thomas 2025[22]Case report11-cm distal stricture, 64-yo postmenopausal, prior failed dilationDVIU + 3-cm Optilume; satisfactory at 6 mo. Sunnybrook reconstructive group called for multi-site collaboration.

Female DCB is investigational and off-label. In one 12-patient series, investigators advised two weeks of sexual abstinence and three months of barrier contraception; none were breastfeeding or trying to conceive, and the authors noted that lactation exposure data for local urethral use were unavailable.[28] In 23 continent volunteers, mean urethral length by intraurethral MRI was 3.8 cm[32]; balloon length and sphincteric overlap require deliberate planning.[28] In one 12-patient off-label series, operators predilated with hydrophilic dilators and placed a 5-cm, 30-Fr balloon with 0.5 cm of the coated segment external to the meatus, then inflated at 10 bar for 10 minutes.[28] The AUA 2023 guideline states that urethroplasty with oral mucosa grafts or vaginal flaps is the best treatment option for female urethral stricture rather than endoscopic treatment. The EAU 2026 guideline weakly recommends initial dilation to 24–41 Fr, repeat dilation with planned weekly 16–18 Fr self-dilation or planned repeat dilation at first recurrence, and strongly recommends urethroplasty at second recurrence when self-dilation is unsuitable or definitive treatment is desired.[31] Candidates for off-label DCB are patients with multiply failed endoscopy or severe surgical-candidacy concerns, after informed consent for off-label use.[4][20][21][22]

Ureteral Technique Concept​

For ureteral strictures, DCB therapy extends balloon dilation and endoureterotomy. The largest published ureteral DCB series used the Lutonix paclitaxel-coated balloon, and a 6-patient series used Optilume.[7][23]

The reported ureteral workflow is:

  1. define the stricture with retrograde or antegrade pyelography,
  2. obtain safe guidewire access across the stricture,
  3. predilate with a high-pressure balloon and confirm no ureteral-wall rupture before drug-coated inflation, as in the reported Lutonix protocol,[7]
  4. inflate a ureter-caliber paclitaxel-coated balloon across the lesion for several minutes,
  5. repeat dilation if needed,
  6. stent or drain according to local protocol,
  7. monitor with imaging and renal function follow-up.

Ureteral Fit​

Potential FitWhy It Is Still Investigational
Short benign ureteral stricturesOnly small clinical series and case reports; mostly not Optilume
Ureteroenteric anastomotic stricturesIncluded in the pilot experience, but heterogeneous and recurrence-prone
Patients who are poor candidates for reconstruction58 heterogeneous cases[24]
Adjunct after endoureterotomy or dilationClinical protocols are not standardized

Reconstructive options include ureteroureterostomy, ureteral reimplantation, and BMG ureteroplasty.It is an emerging endoscopic strategy with limited data.

Ureteral Evidence​

Kallidonis et al. 2022​

This prospective off-label single-arm pilot study used the Lutonix balloon and is the largest published clinical ureteral DCB series.[7][24]

ParameterResult
DeviceLutonix paclitaxel-coated balloon
Patients25
Etiologies / sitesUreteroenteric, lower ureteric, upper ureteric, and ureterovesical strictures
Mean stricture length40 +/- 28.5 mm
Mean follow-up36 +/- 10.5 months
TechniquePredilation with high-pressure balloon, DCB inflation for 4 minutes, repeat up to 3 times if needed
1-year radiologic success after additional dilation was permitted88% (22/25), defined as absent or improved ipsilateral hydronephrosis[7]
Primary patency after one DCB session with nephrostomy removal at 21 days56% (14/25)[7]
Additional dilation32% (8/25)[7]
Failure at 1 year12% (3/25)[7]
ComplicationsOne febrile UTI / pyelonephritis; no major device-specific safety signal

The off-label, single-arm 25-patient Lutonix pilot reported 22/25 (88%) radiologic success at one year; a separate meta-analysis of 19 conventional-balloon series reported 54% ± 14% success at 6–12 months.[7][16] Different populations and endpoints preclude a comparative efficacy conclusion.[7][16]

Other ureteral clinical reports​

Zorzi 2026 described a standardized protocol of high-pressure dilation followed by Optilume in 6 patients (mostly post-ureteroscopy strictures). Technical success was 100%, 4 of 6 (67%) had complete resolution of hydronephrosis and 5 of 6 (83%) were free from reintervention at a median follow-up of 6 months.[23] The 2026 EAU Endourology review combined four small clinical reports (58 cases) and reported 50/58 (86.2%) success by heterogeneous criteria assessed at 1–12 months. Mean follow-up was 20.7 months, but the pooled figure is not a 20.7-month patency estimate; study risk of bias was moderate.[24]

Preclinical Ureteral Paclitaxel Work​

PlatformModelFinding
Paclitaxel and ureteral smooth-muscle cellsIn vitroPaclitaxel inhibited proliferation and type III collagen production without cytotoxicity at tested concentrations[8]
Paclitaxel-eluting balloonPorcine ureterDrug reached submucosa and muscle layers; inflammation was reduced compared with controls[9]
Paclitaxel-eluting metal stentsPig ureterBare metal stents occluded frequently; paclitaxel-eluting stents had less hyperplasia and no occlusions in that model[17]
Paclitaxel-coated polyurethane stentsRat ureteroureterostomyReduced urothelial hyperplastic proliferation compared with uncoated stents[18]
Rapamycin / paclitaxel biodegradable stentsPreclinical biomaterialsSustained release and reduced proliferative / collagen responses in early models[19]

Comparison With Other Endoscopic Options​

ApproachMechanismTypical RoleLimitation
Plain balloon dilationMechanical stretch / fractureLow-morbidity initial treatment for selected short stricturesHigh recurrence; no antifibrotic effect[16]
DVIU / endoureterotomyFull-thickness incision and stentingBetter controlled release of scar than dilation aloneStill recurrence-prone; selection sensitive
DCB dilationMechanical dilation plus local paclitaxelEvidence-supported in recurrent bulbar urethral stricture; investigational in ureterDevice/site evidence mismatch; cost; uncertain repeat-use strategy
Steroid injection adjunctAnti-inflammatory / antifibrotic injectionSelected urethral, bladder-neck, and ureteroenteric protocolsVariable technique and durability
Metallic ureteral stentChronic internal scaffoldUreteral salvage / poor reconstructive candidateEncrustation, migration, surveillance burden
ReconstructionExcision, graft, flap, or substitutionBest durability for complex stricturesMore invasive

Counseling Points​

  • DCB therapy is an endoscopic option for selected strictures.
  • In ROBUST III, adjudicated device- or procedure-related events included postprocedural hematuria (9/79 DCB versus 0/48 controls), dysuria (5/79 versus 0/48), and UTI (5/79 versus 1/48).[26]
  • For the urethra, Optilume has RCT and long-term data, and guideline-supported use is mainly recurrent bulbar strictures <3 cm.
  • For the ureter, DCB evidence consists of small heterogeneous reports using several paclitaxel-coated platforms, including a 25-patient Lutonix series and a six-patient Optilume series; use remains off-label.[7][23][24]
  • After a DCB failure, reassess anatomy and candidacy for definitive reconstruction instead of serial repeat dilation.
  • The label contraindicates use with paclitaxel hypersensitivity and with urologic implants (penile prosthesis or artificial urinary sphincter), and requires treatment of an active urinary tract infection first.[26]
  • Informed consent covers paclitaxel exposure, contraception and off-label use. Men abstain from sex or use a condom for 30 days. Paclitaxel was detectable in semen in 60% (9/15), 39% (5/13) and 8.3% (1/12) at 1, 3 and 6 months.[26] Men with partners of child-bearing potential use highly effective contraception and avoid fathering children for at least 6 months; effects on sperm and spermatogenesis are unknown.[25][26]

Summary​

Drug-coated balloon therapy adds local antifibrotic drug delivery to endoscopic stricture treatment. In the urethra, Optilume is FDA-approved for symptomatic anterior strictures of 3 cm or less in adult men, and the AUA and EAU recommendations apply to recurrent short bulbar strictures.[26][4][25] In the ureter, DCB therapy is supported by a 25-patient Lutonix pilot series, a 6-patient Optilume series and preclinical paclitaxel data. Optilume is not FDA-approved for ureteral use.

Videos​

Drug-Coated Balloon (Optilume)
Operative technique
Drug-Coated Balloon (Optilume)
Operative technique

References​

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  2. 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.

  3. 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.

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  5. 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.

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  11. 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.

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  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Stuehmeier J, Jelisejevas LA, Kink P, Gulacsi A, Horninger W, Rehder P. Optilume drug-coated balloon dilation in complex female urethral stricture. Urol Case Rep. 2022;41:101987. doi:10.1016/j.eucr.2021.101987.

  21. Jelisejevas LA, Tulchiner G, Stuehmeier J, et al. PD05-02 Optilume drug-coated balloon dilation in the treatment of female urethral stricture disease. J Urol. 2025;213(5S):e108. doi:10.1097/01.JU.0001109760.63452.97.02.

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  24. Rico L, Contreras P, Blas L, et al. The role of paclitaxel-coated balloons in treating ureteral or anastomotic strictures: current evidence and future directions from EAU endourology. World J Urol. 2026;44(1):97. doi:10.1007/s00345-026-06196-5.

  25. European Association of Urology. EAU Guidelines on Urethral Strictures (limited update 2026), section 6.2.3.d, drug-coated balloon dilatation. uroweb.org/guidelines/urethral-strictures.

  26. Urotronic. Optilume Urethral Drug Coated Balloon Catheter: Instructions for Use, 1111-003 Rev B (US). Sections 1 to 12 checked September 26, 2026.

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  28. Jelisejevas LA, Tulchiner G, Kink P, Rehder P. "Does Optilume drug-coated balloon dilation compromise female sphincter function?" Int Urol Nephrol. 2025;57(10):3215-3217. doi:10.1007/s11255-025-04513-2

  29. U.S. Food and Drug Administration. Optilume BPH Catheter System (P220029): approval order and indications for use. June 30, 2023. FDA PMA record.

  30. Mahdi MB, Haase RN, Sander 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(1):e103948. doi:10.1136/bmjopen-2025-103948

  31. European Association of Urology. EAU Guidelines on Urethral Strictures (2026 update), section 7.3, disease management in females. Official guideline.

  32. Macura KJ, Genadry R, Borman TL, Mostwin JL, Lardo AC, Bluemke DA. "Evaluation of the female urethra with intraurethral magnetic resonance imaging." J Magn Reson Imaging. 2004;20(1):153-159. doi:10.1002/jmri.20058