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Drug-Coated Balloon Therapy — Optilume

Optilume® (Urotronic, Inc.) is a paclitaxel-coated drug-coated balloon (DCB), the FDA-approved antimitotic device for urethral stricture disease. It combines mechanical urethral dilation with localized paclitaxel delivery to inhibit fibrosis and reduce stricture recurrence. The US label covers symptomatic anterior urethral strictures ≤3 cm in adult men. The AUA Urethral Stricture Disease Guideline Amendment 2023 permits dilation or DVIU combined with a DCB for recurrent bulbar urethral strictures <3 cm, and the EAU 2026 guideline recommends it for short bulbar strictures that have recurred after at least two endoscopic treatments in men unfit for or declining urethroplasty; both selections are narrower than the FDA label.[1][2][18][19]

This article is the device-level deep-dive: mechanism and preclinical tissue pharmacology, the complete ROBUST trial program (I / III with 5-year and 3-year extensions), procedural technique, off-label use patterns from the Sugrue 2026 international survey, and device-specific safety including the Gao 2025 pudendal-artery case. For the class-level comparison against MMC, HA/CMC, PRP, and other adjuncts, see Antimitotics & antifibrotics. For the clinical condition, see Urethral stricture.

Device description and mechanism​

The Optilume DCB is a urethral dilation balloon coated with paclitaxel, a microtubule-stabilizing taxane that produces antiproliferative and antifibrotic effects by preventing cell division, inhibiting fibroblast proliferation, and reducing collagen deposition.[2][3]

Preclinical tissue pharmacology​

  • Will 2011. In canine ureteral smooth-muscle cells (in vitro), paclitaxel 10 and 100 nM significantly inhibited proliferation and 100 nM reduced type III collagen production, without cytotoxicity at concentrations up to 100 nM[3]
  • Barbalias 2018 rabbit urethral model: paclitaxel distributes to all urethral layers (urothelial, submucosal, and smooth-muscle) immediately after DCB inflation; drug and mild inflammation persist at 24 and 48 hours[4]
  • Liourdi 2015 porcine ureteral model: paclitaxel penetrates through urothelium to submucosa and muscle by 12–24 hours, with reduced inflammation compared to conventional balloon dilation[5]

The dual mechanism (immediate mechanical dilation for symptom relief combined with sustained local drug delivery to prevent fibrotic recurrence) is what distinguishes the DCB from plain balloon dilation or DVIU.[2]

Available sizes​

The US catheter is a 0.038-in over-the-wire balloon in 18, 24, 30 and 36 Fr (6–12 mm) diameters, each in 30 mm and 50 mm working lengths. Rated burst pressure is 12 atm for 18 and 24 Fr, 10 atm for 30 Fr and 8 atm for 36 Fr. The coating is spread over the working length at 3.5 µg/mm², which gives a nominal paclitaxel dose of 1,979 µg (18 Fr, 30 mm) to 6,597 µg (36 Fr, 50 mm).[18] For bulbar strictures the IFU advises a diameter slightly larger than the distal healthy urethra, not more than 30% oversized, with a working length 0.5 to 1 cm beyond the stricture on each side; most bulbar ROBUST III cases used 30 Fr.[18] For penile strictures it advises the diameter closest to the distal healthy urethra and does not recommend the 36 Fr balloon there. The 18 to 30 Fr balloons pass through a flexible cystoscope; the 36 Fr balloon does not and is placed side by side with the cystoscope. In ROBUST I, 5-year functional success was higher with the 30 Fr than the 24 Fr balloon (77% versus 38%, as summarized by the EAU), and the 24 Fr/3 cm balloon was associated with more recurrence in real-world data (see below).[18][19][6]

ROBUST I — single-arm long-term durability​

Timepointn evaluableFunctional successFreedom from reinterventionIPSS (baseline → f/u)Qmax change
2 y46 for functional success; 38 with IPSS at 24 mo70%—25.2 → 6.9 (p < 0.0001)Significant ↑[7]
3 y43 for success/reintervention; 33 with IPSS at 3 y67%77%25.2 → 5.5 (p < 0.0001)Significant ↑[8]
5 y43 in functional-success analysis; 31 completed follow-up; 29 with IPSS and 28 with Qmax at 5 y58%71.7% (KM)25.2 → 7.2 (p < 0.001)5.0 → 19.9 mL/s (p < 0.01)[9]

Cohort profile: men with recurrent bulbar strictures ≤2 cm (mean 1.7 prior dilations; 43% with >1 prior dilation).[18][7] At 5 years, Optilume maintained 71.7% freedom from repeat intervention. Mean erectile-function scores did not deteriorate and no serious treatment-related AEs were observed across the entire 5-year study period.[9]

ROBUST III — pivotal multicenter RCT​

The pivotal multicenter single-blind RCT that supported FDA approval.[10]

Design​

  • 127 patients (79 DCB, 48 control) at 22 sites; recurrent anterior strictures ≤3 cm, ≤12F, ≥2 prior endoscopic treatments, IPSS ≥11, Qmax <15 mL/s (average 3.6 prior treatments and 1.7 cm length); about 90% of strictures were bulbar (71/79 DCB, 45/47 control)[10]
  • Randomized 2:1 to Optilume DCB versus standard endoscopic treatment (DVIU or dilation)
  • Exclusions included lichen sclerosus or BXO, prior urethroplasty in the anterior urethra, prior hypospadias repair, dilation or incision within 6 weeks, urethral false passage or fistula, artificial sphincter, sling or urethral or prostatic stent, neurogenic bladder, radiation cystitis and uncontrolled diabetes

Outcomes​

EndpointOptilume DCBControlp
Primary: stricture-free at 6 mo (16 Fr flexible cystoscope or 14 Fr catheter passes; prior repeat treatment counts as failure)74.6% (50/67)26.8% (11/41)<0.0001 (complete case; ITT multiple-imputation difference 44.4%, 95% CI 27.6 to 61.1)[18]
Qmax change at 6 mo (between-arm difference; ITT multiple imputation)+4.78 mL/s favoring Optilume—0.0031[18]
IPSS responder (≥50%) at 12 mo, ITT multiple imputation59.6% (90% CI 49.9 to 69.3)—0.051 against a 50% performance goal, so the goal was not met[18]
Freedom from reintervention at 1 y83.2%21.7%<0.001[10]
Freedom from reintervention at 3 y71%——[11]

3-year extension (Srikanth 2025)[11]​

  • DCB arm had 71.9% Kaplan–Meier freedom from reintervention at 3 years, while 48% (27/56 assessed at 3 years) had at least 30% IPSS improvement without repeat intervention; mean Qmax among evaluable participants was 15.5 mL/s (n = 65) at year 1 and 10.6 mL/s (n = 53) at year 3.[11] The extension does not provide a contemporaneous randomized three-year control comparison.
  • Clinically significant subgroups (≥5 prior dilations, strictures ≥2 cm) showed no statistically detected differences
  • Crossover cohort (control patients who failed standard treatment and opted for DCB) produced a Kaplan-Meier curve closely resembling the original DCB cohort

AUA guideline positioning​

AUA 2023 Statement 11b allows dilation or DVIU combined with a drug-coated balloon for recurrent bulbar strictures <3 cm . The panel restricted the recommendation to recurrent bulbar disease because ROBUST III was not powered for the penile subgroup (about 10% of participants), and it does not recommend repeat DCB use because efficacy of repeat treatment has not been established.[1]

EAU 2026 gives a strong recommendation to offer a DCB for a short (<3 cm) bulbar stricture recurring after at least two endoscopic treatments in patients unfit for or unwilling to undergo urethroplasty. Use beyond that population (penile, membranous, bladder-neck, VUAS, longer, treatment-naive or post-urethroplasty strictures) is described as too limited for a recommendation and is advised within a trial or registry.[19]

FDA labeling is a separate question: the US indication is symptomatic anterior strictures ≤3 cm in adult men, without a recurrent-only or bulbar-only restriction. Penile or primary anterior treatment meeting those criteria is within the anatomical label but has less established evidence than recurrent bulbar disease. Posterior, BNC and VUAS treatment is off-label.[18]

Procedural technique​

Use the current regional manufacturer IFU for the exact catheter.[18]

StepDetail
AnesthesiaGeneral (58% in the Sugrue 2026 survey) or local / sedation[13]
Perioperative medicationFollow endoscopic-procedure guidance for a preprocedure antibiotic when appropriate; the US IFU also recommends an oral NSAID when suitable for the patient.[18]
Imaging and cystoscopyThe US IFU recommends preoperative or intraoperative RUG or VCUG to assess stricture location, length, and lumen narrowing for balloon sizing; cystoscopy can confirm the stricture and guide placement, but usually cannot assess length.[18][19]
Guidewire and placementUnder cystoscopic guidance, pass a 0.038-in or smaller flexible-tip guidewire across the stricture and coil its tip in the bladder. Advance the DCB over the wire through the cystoscope or alongside it, confirming balloon position endoscopically or fluoroscopically.[18]
Pre-dilationThe IFU describes no pre-dilation step. Uncoated balloon or sequential dilators are used in practice; all Optilume patients in ROBUST III were pre-dilated, and published series commonly dilate to ~20F. Urotronic also supplies an uncoated Optilume Basic balloon catheter (0.038-in wire, flexible-cystoscope compatible; IFU 1151-001 Rev C) that is indicated for urethral stricture dilation and carries a pre-dilation label[20]
Balloon handlingDry gloves or gauze, no wiping or immersion, no inflation before the balloon reaches the stricture; a balloon that contacts fluid is replaced. Do not force the wire or DCB against unexplained resistance. If withdrawal through a cystoscope meets resistance, stop and remove the wire and DCB together as one unit. If the balloon fails before or below the rated burst pressure it is replaced; after inflation to the rated burst pressure, do not repeat with a second device.[18]
Optilume inflationChoose balloon diameter/length for the stricture and adjacent urethra (sizing above); leave the balloon uninflated across the stricture for ≥60 seconds to hydrate the coating, then inflate with sterile saline (or a 1:1 normal saline–contrast mixture when using fluoroscopy) to the rated burst pressure for ≥5 minutes without exceeding it. Never use air or any gaseous medium.[18] Deflate fully before withdrawal; do not manipulate it inflated
Post-procedure catheter12–14F Foley for at least 2 days, or longer standard of care per US IFU[18]
Follow-upUroflowmetry, IPSS, cystoscopy per institutional protocol

Practice-variation signal — Sugrue 2026​

International survey of 102 Optilume users revealed significant practice variation in catheter duration, perioperative antibiotic use, and postprocedure contraception advice, reflecting the early-adoption phase of this technology.[13]

Use beyond the best-supported trial population​

In the Sugrue 2026 survey (n = 102), respondents reported willingness to offer DCB beyond the AUA guideline population; the survey did not measure patient-level use or outcomes.[13] The AUA issues recommendations, not regulatory approvals; the label distinction below follows the US IFU:[13][18]

Use pattern% of surveyed urologists
Penile urethral strictures (anterior label if other criteria met; limited subgroup evidence)65%
Primary / first-line treatment (not excluded by anterior label; evidence gap)64%
Bladder-neck stenoses (off-label)65%

Higher-volume users (≥10 / y) were more likely to perform DCB under flexible cystoscopy (OR 5.14), for bladder-neck strictures (OR 4.66), and for recurrences (OR 6.92).[13]

Posterior urethral stenosis (BNC / VUAS)​

Berg 2025 retrospective comparative study (n = 141): DCB dilation was associated with longer recurrence-free survival than standard endoscopic treatment (p = 0.013); treatment modality was associated with recurrence-free survival on multivariable analysis (HR 0.40; 95% CI 0.19–0.87; p = 0.021). Qmax improved from 9 to 22 mL/s (p = 0.001).[14]

Membranous / sphincteric strictures​

Jelisejevas 2025 retrospective series (n = 53; 35 membranous strictures, 18 VUAS extending into the sphincter; median 2.5 prior interventions, median length 3 cm; dilation to 20 Fr, then a 30 Fr DCB at 10 bar for 10 minutes): 12/18 men with VUAS and 24/35 with membranous strictures were reported free from recurrence and reintervention at median 13.3-month follow-up, with authors reporting no de novo incontinence, although Table 1 lists 19 incontinent before and 21 after treatment. Two men whose post-prostatectomy incontinence had been masked by VUAS obstruction experienced recurrent leakage after dilation; the authors classified this as unmasking rather than de novo incontinence.[12]

Penile urethral strictures​

Salem 2025 small multicenter uncontrolled series (n = 8): median IPSS improved from 25.5 to 5.0 (p < 0.01), with no retreatment at median 16.5-month follow-up. Stricture lengths were 1.5–8.0 cm, so some exceeded the US 3-cm indication; routine anatomical patency was not assessed. For meatal lesions, the investigators pre-immersed the coated balloon in saline, contrary to the US IFU instruction against immersion. The series is insufficient to establish routine penile-stricture efficacy.[15][18]

Real-world 319-patient TURNS experience​

Patel 2026 (260 anterior strictures, 59 posterior stenoses; median follow-up only 5.7 months): 1-year functional recurrence-free survival 78.4% for anterior strictures and 75.8% for posterior stenoses. Independent predictors of recurrence of any kind:[6]

  • Strictures after hypospadias repair: HR 5.21 (95% CI 1.06–25.6; p = 0.042)[6]
  • 24F/3 cm DCB use: HR 3.64 (95% CI 1.10–12.09; p = 0.035)[6]

Anatomical recurrence-free survival was lower than freedom from symptomatic recurrence requiring retreatment (66.4% anterior and 59.4% posterior); some patients with recurrent narrowing did not undergo repeat treatment.[6]

FIRST-CARE — the pending first-line RCT​

FIRST-CARE (NCT06827210) is a multicenter, single-blind RCT protocol planning to enroll 140 treatment-naïve patients with single bulbar urethral strictures ≤3 cm to evaluate Optilume DCB as first-line treatment versus standard endoscopic management. Primary endpoint: freedom from repeat intervention at 12 months.[17]

Safety profile​

ConcernEvidence
Common AEsUTI, post-procedural hematuria, dysuria — generally mild and self-limited; in ROBUST III, device- or procedure-related post-procedural hematuria occurred in 11.4% (9/79) of the DCB arm versus 0% of controls, dysuria in 6.3% versus 0%, and urinary tract infection in 6.3% versus 2.1%; events were mild and generally resolved within 30 days (the EAU guideline reports 11.4% vs 2.1% while discussing hematuria and dysuria, without defining a combined endpoint)[1][9][10][18][19]
Serious treatment-related AEsNone reported in ROBUST I through 5 years. In ROBUST III no participant met the primary safety composite (fistula, unresolved de novo SUI, urethral rupture) through 3 months, and each arm had two related serious events (aspiration during anesthesia and post-procedural UTI or sepsis, one each)[9][10][18]
Erectile functionNo deterioration detected in measured group scores through reported follow-up[9][11]
ContinenceIn this 53-patient sphincteric series, the authors reported no de novo incontinence, but prior post-prostatectomy leakage re-emerged in two men when VUAS obstruction was relieved (19 with incontinence before versus 21 after; median follow-up 13.3 months).[12]
Rare vascular injuryOne case report (Gao 2025) of recurrent massive urethral bleeding requiring selective embolization of the internal pudendal artery after Optilume use in a post-urethroplasty recurrence[16]
Systemic paclitaxel concernsPaclitaxel is delivered locally, and no serious treatment-related adverse events were reported in ROBUST I through 5 years. It is a genotoxic aneugen; in the ROBUST III pharmacokinetic substudy, paclitaxel was detectable in semen in 60% (9/15) at 1 month, 39% (5/13) at 3 months and 8% (1/12) at 6 months (IFU). The effect on sperm and spermatogenesis is unknown[9][18]
Systemic exposureIn the 15-man pharmacokinetic sub-study, mean peak plasma paclitaxel was 0.12 ng/mL and mean plasma concentration fell below the 0.10 ng/mL quantitation limit by 5 hours; mean urine concentration fell below it by 30 days, although 4/15 still had measurable paclitaxel in urine then. The IFU reports ROBUST mortality of 0.6 deaths per 100 patient-years and discusses the vascular paclitaxel-device mortality signal as a different application (drug deposited on the urethra, not in the blood)[18]
Contraception — required counselingAbstain from sex or use condoms for 30 days. Men with partners of childbearing potential should use highly effective contraception and avoid fathering a child for at least 6 months; paclitaxel can persist in semen.[18][19]
Drug interactionsFormal Optilume interaction studies have not been done. Review medicines with known paclitaxel interactions; paclitaxel is metabolized by CYP2C8/CYP3A4 and is a P-glycoprotein substrate.[18]
Contraindications / infectionUS contraindications include paclitaxel-related hypersensitivity and urologic implants such as penile implants or AUS. Resolve active UTI before treatment.[18]

Limitations and unanswered questions​

Several evidence gaps remain:[2][6][13]

  • Durability in complex or longer strictures (>3 cm) is uncertain
  • Repeated DCB use has not been validated; the AUA does not recommend it and the IFU notes that repeat treatment of the same stricture increases paclitaxel exposure with unknown risk[1][18]
  • Post-urethroplasty recurrence. The role of DCB as salvage therapy requires further investigation (the Gao 2025 bleeding case occurred in this setting)
  • Penile urethral strictures. The ROBUST III trial was not powered for this subgroup
  • First-line use. Awaiting FIRST-CARE results
  • Cost-effectiveness. Described as "cost-effective" in reviews, but formal health-economic comparisons versus urethroplasty and repeated DVIU are limited
  • Long-term oncologic safety. The US IFU states that no long-term studies have evaluated Optilume's carcinogenic potential. The US IFU lists urethral cancer among serious adverse events in ROBUST III (1/79 DCB versus 0/48 controls), but not among events deemed treatment-related.[18] ROBUST I reported no serious treatment-related adverse events through five years.[9]

Evidence Summary​

DomainEvidence levelKey source
FDA label / guidelineRegulatory indication / conditional (AUA) and strong (EAU) guideline recommendationsUS IFU; AUA 2023 Statement 11b; EAU 2026[1][18][19]
Pivotal RCTLevel 1ROBUST III — Elliott 2022[10]; Srikanth 2025 3-year[11]
5-year single-arm durabilityLevel 2DeLong 2025 ROBUST I 5-year[9]
Preclinical tissue PKPreclinicalWill 2011[3]; Barbalias 2018[4]; Liourdi 2015[5]
Posterior stenosis (off-label)Level 3 (comparative retrospective)Berg 2025[14]
Membranous / sphincteric (off-label)Level 3Jelisejevas 2025[12]
Penile strictures (limited evidence)Level 4 (small series)Salem 2025[15]
Real-world 319-patient cohortLevel 3Patel 2026 TURNS[6]
Practice-pattern surveyLevel 4Sugrue 2026[13]
Pending first-line RCTOngoingFIRST-CARE protocol[17]
Vascular-injury caseLevel 5Gao 2025[16]

Clinical Positioning​

  • Use the recurrent bulbar evidence to guide selection, and explain alternatives including urethroplasty. Regulatory anatomy and guideline selection are distinct, as detailed above.[1][18]
  • ROBUST III supports benefit over repeat standard endoscopy in its selected recurrent-stricture population. The three-year extension and ROBUST I five-year single-arm results support durability but do not compare DCB with urethroplasty.[9][10][11]
  • Do not change balloon size solely to avoid the observed 24F/3-cm association. Observational device-size associations may reflect anatomy and selection; use the IFU sizing method. The 24F/3-cm and hypospadias-repair groups each contained only eight patients, so their recurrence estimates are imprecise.[6][18]
  • Posterior, BNC and VUAS use remains off-label with mainly retrospective evidence. The small series reported no new incontinence; it provides no safety comparison with reconstruction or basis for routine use.[12][14]
  • Repeat DCB and routine first-line treatment remain evidence gaps.[1][17]
  • Follow the device precautions and contraception intervals above.[16][18] Discuss bleeding, infection and recurrence.[18]

See Also​

Videos​

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

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. 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. 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

4. Barbalias D, Lappas G, Ravazoula P, et al. "Evaluation of the distribution of paclitaxel after application of a paclitaxel-coated balloon in the rabbit urethra." J Endourol. 2018;32(5):381–386. doi:10.1089/end.2017.0935

5. 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

6. 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. 2026;207:233–238. doi:10.1016/j.urology.2025.10.025

7. Mann RA, Virasoro R, DeLong JM, et al. "A drug-coated balloon treatment for urethral stricture disease: two-year results from the ROBUST I study." Can Urol Assoc J. 2021;15(2):20–25. doi:10.5489/cuaj.6661

8. 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

9. 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

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. 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

12. Jelisejevas LA, Tulchiner G, Rehder P. "Optilume drug-coated balloon dilation for male sphincteric (membranous) urethral strictures: 53 consecutive cases." J Clin Med. 2025;14(23):8369. doi:10.3390/jcm14238369

13. Sugrue DD, O'Connor J, Białek Ł, et al. "Practices in urethral stricture management with drug-coated balloon dilatation: an international survey." World J Urol. 2026;44(1):285. doi:10.1007/s00345-026-06343-y

14. Berg EK, Mehmedovic S, Askari D, et al. "Efficacy of drug-coated balloon dilation vs endoscopic standard treatment in posterior urethral stenosis: a real-world comparative study." Urology. 2025;206:164–170. doi:10.1016/j.urology.2025.07.034

15. Salem J, Menendez-Suarez JJ, Tosev G, Borgmann H, Kuru T. "Efficacy and mid-term outcomes of paclitaxel-coated balloon (Optilume) for penile strictures." J Clin Med. 2025;14(17):6022. doi:10.3390/jcm14176022

16. Gao Y, Mukherjee S, Aydin A, Shekho M, Winkler M. "An unusual case of recurrent massive urethral bleeding following Optilume urethral dilatation needing selective embolisation of the bleeding vessel." Ann R Coll Surg Engl. 2025. doi:10.1308/rcsann.2025.0088

17. 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

18. Urotronic. Optilume Urethral Drug Coated Balloon Catheter: US Instructions for Use, 1111-003 Rev B. Current manufacturer-hosted US IFU accessed September 12, 2026. Instructions for use.

19. Lumen N, Campos-Juanatey F, Dimitropoulos K, et al. EAU Guidelines on Urethral Strictures (limited update). European Association of Urology; 2026. Section 6.2.3.d, drug-coated balloon dilatation. uroweb.org/guidelines/urethral-strictures

20. Urotronic. Optilume Basic Urological Balloon Dilation Catheter: Instructions for Use, 1151-001 Rev C. Checked September 26, 2026.