Skip to main content

DVIU and Urethral Dilation

Direct vision internal urethrotomy (DVIU) and urethral dilation are the two core endoscopic treatments for male urethral stricture disease.[1][2][3] Both open the narrowed lumen without excising the scar, both are low morbidity, both are useful for urgent access, and both have modest long-term durability outside carefully selected short bulbar strictures.[1][2][3]

The AUA guideline treats dilation and DVIU as interchangeable options for initial treatment of appropriate short strictures, with best outcomes in short bulbar disease and sharply diminishing success in longer, recurrent or penile strictures.[1] For definitive reconstruction strategy, see Urethral Reconstruction Principles. For paclitaxel-enhanced endoscopic treatment, see Drug-Coated Balloon Therapy. For Sachse's introduction of direct-vision urethrotomy, see the History of Urethral Surgery.

Guideline Position​

ScenarioAUA-Relevant GuidancePractical Meaning
Primary, single, nonobliterative bulbar stricture <2 cmAUA conditionally permits either dilation or DVIUChoose based on anatomy, surgeon preference, equipment, and patient goals; urethroplasty is also an initial option[1][17]
Urgent retention / need for catheterizationDilation, DVIU, or suprapubic cystostomy may be usedTreat as temporizing access, then stage the stricture properly[1]
Catheterization after dilation/DVIUCatheter removal after 24-72 hours is reasonableNo evidence that >72 hours improves safety or outcome[1]
Recurrent anterior stricture after failed dilation/DVIUOffer urethroplasty instead of repeated endoscopic managementFailure rates exceed 80% for a further endoscopic procedure, and repeated endoscopy can lengthen the stricture and complicate later urethroplasty[1][19]
Recurrent bulbar stricture <3 cmDilation or DVIU combined with a drug-coated balloon may be offered Discuss this option alongside urethroplasty; balloon treatment is not a required step before reconstruction[1][4]
Long bulbar stricture >=2 cmOffer urethroplasty as initial treatmentEndoscopic success is poor as length increases (about 20% for bulbar strictures >4 cm versus >80% for buccal graft urethroplasty)[1][19]

AUA reports similar long-term outcomes for dilation and DVIU in short strictures, with success of 35-70% and the best results below 1 cm.[19] EAU 2026 adds three strong recommendations: do not use DVIU for penile strictures, do not use DVIU/dilatation as sole treatment for strictures >2 cm, and do not repeat DVIU/dilatation more than twice when urethroplasty is viable.[17] Urethroplasty may also be offered as initial treatment for a short bulbar stricture after shared decision-making. The tradeoff is greater durability at the cost of anesthesia, morbidity, and recovery.[1][5]

Definitions and Principles​

ProcedureMechanismCore Limitation
DVIUCold knife or laser makes a controlled full-thickness incision through the stricture scar under direct visionThe wound can heal by recurrent scar contraction
Urethral dilationSequential dilators, sounds, followers, or balloon dilation stretch and split the narrowed segmentScar is disrupted but not excised or reconstructed

Both procedures rely on the same biologic bargain: a short scar is opened, splinted briefly, and allowed to re-epithelialize before it recontracts. That bargain works best when the stricture is short, bulbar, nonobliterative, and first-time.[1][2][3]

When Endoscopic Treatment Makes Sense​

Good CandidatePoor Candidate
First presentation of a short bulbar stricturePenile stricture
Length <1-2 cmBulbar stricture >=2 cm, especially >4 cm
Thin scar / limited spongiofibrosisDense spongiofibrosis or obliteration
Patient needs urgent drainage or temporary accessRecurrent anterior stricture after failed DVIU/dilation
Patient prioritizes lowest morbidity after counselingLichen sclerosus, hypospadias-associated, radiation-associated, or complex recurrent disease
Poor candidate for urethroplastyPatient wants the most durable definitive repair

Repeated endoscopic management can delay definitive repair and increase cumulative instrumentation trauma.

Urethral Dilation Techniques​

Filiforms and Followers​

A small filiform is passed through a tight stricture and sequential followers are attached to dilate the lumen, often up to approximately 24 Fr. This can traverse very tight strictures but is a blind technique and can create false passages, instrument breakage, or traumatic bleeding if forced.[3]

Metal Sounds​

Van Buren or similar sounds are passed sequentially. They provide tactile feedback and are reusable, but they are also blind instruments. The surgeon must respect urethral curvature, stop when resistance is abnormal, and avoid turning dilation into a perforation exercise.

Balloon Dilation​

Balloon dilation applies radial force across the stricture rather than serial axial shearing. It may be performed under endoscopic or fluoroscopic guidance. Direct-vision balloon dilation combines visual confirmation with controlled expansion.[6]

In Beeder et al.'s retrospective uncoated-balloon series of short bulbar or membranous strictures, clinical failure (symptom recurrence or further stricture management) occurred in 46/91 (50%) with median 12-month follow-up; 75/91 (82%) had prior stricture treatment.[7]

Guidewire Principle​

For urgent catheterization or tight strictures, pass a guidewire under cystoscopic or fluoroscopic vision and dilate over it when feasible. EAU weakly recommends visually controlled dilation in preference to blind dilation.[17] If the wire cannot be passed confidently into the bladder, stop and use cystoscopy, fluoroscopy, suprapubic access, or referral.

DVIU Technique​

For elective DVIU or dilation, obtain a preoperative urine culture, treat bacteriuria or UTI before instrumentation, and give intraoperative antibiotic prophylaxis according to local resistance guidance.[17]

Standard Cold-Knife DVIU​

  1. Perform cystourethroscopy and confirm the stricture location, lumen, and estimated length.
  2. Pass a safety guidewire into the bladder whenever possible.
  3. Advance a cold-knife optical urethrotome to the distal face of the stricture.
  4. Incise the scar longitudinally, traditionally at 12 o'clock, until healthy vascular tissue is seen.
  5. Extend the incision across the full stricture into normal proximal urethra.
  6. Place a Foley catheter, usually 16-18 Fr, for 24-72 hours.

The goal is a full-thickness scar release, not a superficial mucosal scratch. A shallow cut behaves like inadequate dilation and fails predictably. The cystoscope should not be advanced through the stricture to confirm patency before the incision is made: passing an instrument across the narrowed segment mechanically dilates it and changes the controlled-incision step that follows.[22]

Laser DVIU​

Ho:YAG or other lasers can be used instead of a cold knife, particularly when flexible access is useful. EAU 2026 now strongly recommends choosing either an energy-based or cold-knife technique according to operator experience and available resources.[17] The favorable initial candidate remains a single, nonobliterative bulbar stricture shorter than 2 cm; penile or long strictures remain poor candidates.[17] One described Ho:YAG setup passes a 200-micron fiber through the cystoscope working channel, steadied with an open-ended catheter or laser bridge, at 0.5-1 J and 5-10 Hz for a 12 o'clock incision; the fiber should not be fired on the safety guidewire, which can damage or sever its coating.[22]

Incision Direction​

The classic 12 o'clock bulbar incision must not be generalized to posterior stenoses. Avoid deep 6 or 12 o'clock incisions in VUAS or radiation-induced bulbomembranous stenosis because of rectal injury and urosymphyseal fistula risk. Completely obliterated posterior stenosis requires reconstructive assessment rather than blind incision.[17] Before endoluminal treatment of VUAS or radiation-associated bulbomembranous stenosis, counsel about de novo or worsened urinary incontinence; across heterogeneous posterior series, EAU reports de novo incontinence up to 25% and worsening of existing incontinence up to 15%.[17]

A single-center 2005 trial randomized 562 patients with short (<1.5 cm) inflammatory urethral strictures to an incision tailored by preoperative ultrasound to the site of spongiofibrosis (n=319) or a fixed 12 o'clock incision (n=243); overall recurrence was 44.5% versus 51.5% at mean follow-up of 38.7 and 37.9 months, respectively. Reported subgroup recurrence was 67.5% versus 83% for circumferential fibrosis and 55.2% versus 72.3% for combined dorsal-and-ventral fibrosis. The study did not report subgroup significance testing, and ultrasound-tailored incision placement has not been adopted into current guideline recommendations.[23]

Incision number varies by surgeon: among 431/1,262 respondents (34%) to a national AUA survey, 86.3% reported a single 12 o'clock incision and 12.1% reported multiple radial incisions; this survey did not compare recurrence outcomes.[24]

DVIU vs Dilation Outcomes​

The best evidence synthesis shows no clear durable superiority of DVIU over dilation for uncomplicated strictures. The Cochrane review found no statistically significant difference between urethrotomy and dilation, with wide confidence intervals and generally low-quality evidence.[3]

FindingEvidence Signal
DVIU and dilation are similar for initial short stricturesAUA guideline treats them as interchangeable[1]
Best outcomes occur in short bulbar stricturesHighest success in very short lesions, especially around 1 cm[1][2]
Median time to recurrence is often earlyKluth et al. reported median recurrence at 6 months after DVIU[8]
Prior DVIU predicts failurePrior DVIU was the only independent recurrence predictor in the Kluth series[8]
Repeat endoscopy performs poorlyAUA recommends urethroplasty over repeated endoscopic management for recurrent anterior strictures; EAU advises against more than two DVIU/dilatations if urethroplasty is viable[1][17]
Urethroplasty is more durableOPEN trial: fewer reinterventions after urethroplasty than urethrotomy[5][9]

In a single-center retrospective review of 136 men who underwent urethrotomy for simple strictures (1994 to 2009), 36 with complex strictures were excluded and 24 were lost to follow-up, leaving 76 for analysis. The Kaplan-Meier stricture-free rate was 8% after the first urethrotomy (median time to recurrence 7 months), 6% after the second, 9% after the third and 0% after the fourth and fifth. In this small series, exclusions and attrition limit application of these estimates to short bulbar strictures.[25]

Practical Success Pattern​

Stricture TypeEndoscopic Outlook
First-time bulbar, <1 cmBest endoscopic candidate
First-time bulbar, 1-2 cmReasonable initial DVIU/dilation after counseling
Bulbar >=2 cmUrethroplasty usually preferred
Bulbar >4 cmEndoscopic success may be around 20% or worse; reconstruction favored[1]
Penile urethral stricturePoor DVIU/dilation candidate; urethroplasty favored
Recurrent anterior after failed DVIU/dilationUrethroplasty preferred; repeat endoscopy failure often >80%[1]

OPEN Trial​

The OPEN trial randomized men with recurrent bulbar urethral stricture to open urethroplasty or endoscopic urethrotomy.[5][9]

EndpointUrethroplastyUrethrotomyInterpretation
Voiding symptomsImprovedImprovedSimilar symptom improvement at 24 months
ReinterventionLess frequentMore frequentUrethroplasty reduced repeat intervention (HR 0.52)[5][9]
Cost over 24 monthsHigherLowerUrethrotomy appeared more cost-effective over short horizon
Evidence horizonFewer reinterventions during the trialMore reinterventions during the trialSymptoms and costs were assessed over 24 months; reinterventions were tracked for at least two and up to four years, without establishing lifetime durability

The trial is useful because it keeps the counseling honest: endoscopy can improve symptoms, but urethroplasty is more durable.

Complications​

ComplicationDVIUDilation
Bleeding / hematuriaCommonly mild; can be significantUsually mild unless traumatic
False passagePossible, especially without guidewireClassic risk with blind dilation
ExtravasationPossible after deep incisionPossible after traumatic dilation
UTI / cystitisLow but real riskLow but real risk
EpididymitisReportedReported
Urinary retentionPossible after catheter removalPossible after catheter removal
Pain / dysuriaCommon short-termCommon short-term
Erectile dysfunctionReported after cold-knife DVIU (5.3% in a systematic review); risk appears higher with penile strictures[17]—
Failure to traverseDense strictures may require suprapubic access or reconstructionTightness can prevent safe dilation

Catheter and Follow-Up​

The AUA guideline notes catheter durations from 1-8 days in the literature but no evidence that catheterization beyond 72 hours improves outcome after uncomplicated dilation or DVIU; it states the catheter may be removed within 72 hours .[1][19]

Typical practice:

  • Foley catheter removal within 72 hours after uncomplicated standard DVIU or uncoated dilation, per the EAU weak recommendation[17]; after Optilume dilation, its 1111-003 Rev B IFU specifies a lubricious 12–14 Fr Foley for at least two days or the local standard of care, whichever is longer,[26]
  • earlier removal when bleeding is minimal and access was atraumatic,
  • longer drainage only for complex incisions, extravasation concern, infection, or surgeon-specific posterior stenosis protocols,
  • follow-up with symptoms, uroflow/PVR, and cystoscopy or urethrography when recurrence is suspected.

Neither the AUA nor the EAU stricture guideline gives a DVIU- or dilation-specific VTE recommendation. These are brief endoscopic procedures, usually outpatient; apply the general risk framework (age, obesity, prior VTE, malignancy, prolonged operation or immobility) on the VTE Prophylaxis page.

Intermittent Self-Dilation​

Intermittent self-dilation (ISD) can reduce or delay recurrence after DVIU/dilation but turns the stricture into a maintenance condition. It is most appropriate for patients who are not urethroplasty candidates, decline reconstruction, or need temporizing management.

EvidenceTakeaway
AUA guidelineSelf-catheterization after DVIU may be recommended to maintain temporary patency in patients who are not urethroplasty candidates; schedules vary[1]
Cochrane ISD reviewISD may reduce recurrence (RR 0.70, 95% CI 0.48-1.00), but the trials were small, at high risk of bias, and the evidence is very low quality[10]
EAU 2026Weak recommendation to use ISD to stabilise the stricture after dilatation/DVIU when urethroplasty is not viable; adding intraurethral corticosteroid to ISD is also a weak recommendation (stabilisation 77% vs 64%). One trial (n=48) found no significant difference between 6 and 12 months of ISD[17]
Scheipner et al.In a prospective 121-man ISD-after-DVIU cohort, patient-reported quality of life did not worsen; 11 (9%) developed stricture recurrence over median 17-month follow-up, and the median complication rate was 3.3% per six-month ISD interval[11]
Lubahn et al.In a separate multicenter survey of 85 men on ISD (median 3 years), overall quality of life was poor (median 7.0 ± 2.6 on a 1-10 scale, poor defined as ≥7); difficulty catheterizing and younger age independently predicted worse quality of life, and posterior-urethral stricture was associated with more difficulty and worse quality of life[21]

These two patient-reported cohorts differ in follow-up duration, instrument and population (Scheipner surveyed patients after DVIU specifically; Lubahn surveyed a longer-duration, multicenter ISD population with more posterior strictures).

Adjunctive Pharmacology​

Injected or instilled agents at the time of DVIU are used to reduce recurrence, but the evidence is limited and low certainty. EAU 2026 advises intralesional injections only within a clinical trial .[12][17] The class-level pharmacology is covered in Antimitotics & Antifibrotics.

AdjunctEvidence Signal
Mitomycin CStrongest adjunct evidence in the Pang meta-analysis (intralesional OR 0.23 for recurrence), though the underlying trials are small and at high risk of bias; used for recurrent bulbar/bulbomembranous strictures and BNC/VUAS salvage[12][13][14]
TriamcinoloneReduces recurrence in some studies, but protocols and adverse events vary and trials are at high risk of bias; EAU 2026 rates intralesional steroid low certainty[12][17]
Drug-coated balloonROBUST III showed 1-year freedom from reintervention 83.2% vs 21.7% for DCB vs standard DVIU/dilation in recurrent anterior strictures; guideline-supported use is recurrent bulbar <3 cm. In the DCB arm, freedom from reintervention was about 71% at 3 years. EAU 2026 strongly recommends DCB for a short (<3 cm) bulbar stricture recurring after at least two endoscopic treatments in patients unfit for or declining urethroplasty; in a 15-man nonrandomized pharmacokinetic cohort, paclitaxel was detectable in semen in 1/12 men who provided a sample at six months. The Optilume 1111-003 Rev B IFU directs abstinence or condom use for 30 days to limit partner exposure and highly effective contraception with avoidance of fathering a child for at least six months when the partner can conceive. It contraindicates use with known hypersensitivity to paclitaxel or related compounds or with urologic implants such as an artificial urinary sphincter or penile implant; it warns against use during active UTI. For drug transfer, the Optilume Rev B IFU instructs leaving the coated balloon uninflated in the urethra for at least 60 seconds before inflation to its rated burst pressure, without exceeding it, and maintaining pressure for at least five minutes[1][4][17][18][20][26]
PRP, HA/CMC, other agentsEmerging or lower-certainty adjuncts; not routine standard

In a multi-institutional mitomycin C injection series summarized in EAU 2026, four of 55 patients (7%) experienced grade 3 complications, including osteitis pubis, bladder-neck necrosis, and rectourethral fistula; three required urinary diversion. EAU weakly recommends restricting intralesional injections to clinical trials.[17]

Post-Urethroplasty Recurrence​

Short annular recurrence after urethroplasty is a different clinical problem from untreated stricture disease. Endoscopic treatment may be reasonable, but results vary by repair type and recurrence pattern.

StudyKey Finding
Sukumar et al. (TURNS)At median five-month follow-up in 53 men, cystoscopic success (passage of a 17 Fr cystoscope without force) was 42% overall; DVIU succeeded in 21/43 (49%) versus dilation in 1/10 (10%), and DVIU success was 53% after substitution repair versus 13% after EPA (p=0.005)[15]
Bandini et al.After ventral onlay BMG failure, 12-month success after the first through fourth rescue DVIU was 66.3%, 62.5%, 37.5%, and 25%; open retreatment after failed rescue DVIU had 75–92.3% success at 12 months in this cohort.[16]

Decision Framework​

Clinical ScenarioPreferred Strategy
First-time short bulbar strictureDVIU or dilation reasonable; urethroplasty also acceptable if patient wants durability
First-time long bulbar stricture >=2 cmUrethroplasty
Penile strictureUrethroplasty, often graft or staged repair depending tissue
Recurrent anterior stricture after failed DVIU/dilationUrethroplasty
Recurrent bulbar stricture <3 cm; patient requests another endoscopic optionDiscuss urethroplasty; AUA conditionally permits DVIU or dilation plus a drug-coated balloon, while EAU strongly recommends drug-coated-balloon dilation after at least two prior endoscopic treatments only when the patient is unfit for or declines urethroplasty[1][17]
Urgent urinary retentionGuidewire dilation, DVIU, or suprapubic cystostomy, followed by definitive staging
Poor surgical candidateDVIU/dilation may relieve obstruction; ISD can stabilize the stricture after endoscopy. For recurrent bulbar stricture after DVIU when urethroplasty is not viable, EAU weakly recommends a temporary stent to prolong time to recurrence; across urethral stent series, failure or reintervention is reported in 30–53%, and EAU strongly recommends against permanent stents. Use intralesional injections only within a clinical trial .[1][17]
Short recurrence after substitution urethroplastyConsider DVIU before open redo in selected annular recurrences

Operative Pearls​

  • Stage the stricture before treating it when possible: RUG/VCUG, cystoscopy, and sometimes ultrasound define whether endoscopy is reasonable.
  • Use a guidewire for tight strictures and urgent catheterization.
  • Do not force blind dilation. False passage creation converts a simple problem into a worse one.
  • A short first-time bulbar stricture is the endoscopic sweet spot.
  • A penile, long, obliterative, lichen sclerosus, or multiply recurrent stricture is not the endoscopic sweet spot.
  • Remove uncomplicated catheters early, usually within 24-72 hours.
  • After one failed endoscopic treatment, pause and re-stage instead of reflexively repeating the same operation.
  • Explain that ISD is maintenance and that urethroplasty is the durable option for recurrence.

Summary​

DVIU and urethral dilation are low-morbidity, interchangeable first-line endoscopic options for carefully selected short bulbar strictures and useful temporizing tools for urgent access.[1] Their long-term durability is limited, especially for long, penile, recurrent, ischemic, or complex strictures. After failed dilation or DVIU, repeated endoscopic management usually performs poorly and urethroplasty should be offered. Adjuncts such as mitomycin C, intermittent self-dilation, and drug-coated balloons can improve selected endoscopic outcomes.

Videos​

DVIU / Urethral Dilation
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. Hampson LA, McAninch JW, Breyer BN. Male urethral strictures and their management. Nat Rev Urol. 2014;11(1):43-50. doi:10.1038/nrurol.2013.275.

  3. Wong SS, Aboumarzouk OM, Narahari R, O'Riordan A, Pickard R. Simple urethral dilatation, endoscopic urethrotomy, and urethroplasty for urethral stricture disease in adult men. Cochrane Database Syst Rev. 2012;12:CD006934. doi:10.1002/14651858.CD006934.pub3.

  4. 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.

  5. Goulao B, Carnell S, Shen J, et al. Surgical treatment for recurrent bulbar urethral stricture: a randomised open-label superiority trial of open urethroplasty versus endoscopic urethrotomy (the OPEN trial). Eur Urol. 2020;78(4):572-580. doi:10.1016/j.eururo.2020.06.003.

  6. Gelman J, Liss MA, Cinman NM. Direct vision balloon dilation for the management of urethral strictures. J Endourol. 2011;25(8):1249-1251. doi:10.1089/end.2011.0034.

  7. Beeder LA, Cook GS, Nealon SW, et al. Long-term experience with balloon dilation for short bulbar and membranous urethral strictures: establishing a baseline in the active drug treatment era. J Clin Med. 2022;11(11):3095. doi:10.3390/jcm11113095.

  8. Kluth LA, Ernst L, Vetterlein MW, et al. Direct vision internal urethrotomy for short anterior urethral strictures and beyond: success rates, predictors of treatment failure, and recurrence management. Urology. 2017;106:210-215. doi:10.1016/j.urology.2017.04.037.

  9. Pickard R, Goulao B, Carnell S, et al. Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT. Health Technol Assess. 2020;24(61):1-110. doi:10.3310/hta24610.

  10. Jackson MJ, Veeratterapillay R, Harding CK, Dorkin TJ. Intermittent self-dilatation for urethral stricture disease in males. Cochrane Database Syst Rev. 2014;(12):CD010258. doi:10.1002/14651858.CD010258.pub2.

  11. Scheipner L, Jankovic D, Jasarevic S, et al. Patient reported outcomes of intermittent self-dilatation after direct vision internal urethrotomy. Neurourol Urodyn. 2024;43(3):664-671. doi:10.1002/nau.25390.

  12. Pang KH, Chapple CR, Chatters R, et al. A systematic review and meta-analysis of adjuncts to minimally invasive treatment of urethral stricture in men. Eur Urol. 2021;80(4):467-479. doi:10.1016/j.eururo.2021.06.022.

  13. Farrell MR, Lawrenz CW, Levine LA. Internal urethrotomy with intralesional mitomycin C: an effective option for endoscopic management of recurrent bulbar and bulbomembranous urethral strictures. Urology. 2017;110:223-227. doi:10.1016/j.urology.2017.07.017.

  14. Rozanski AT, Zhang LT, Holst DD, et al. The effect of radiation therapy on the efficacy of internal urethrotomy with intralesional mitomycin C for recurrent vesicourethral anastomotic stenoses and bladder neck contractures: a multi-institutional experience. Urology. 2021;147:294-298. doi:10.1016/j.urology.2020.09.035.

  15. Sukumar S, Elliott SP, Myers JB, et al. Multi-institutional outcomes of endoscopic management of stricture recurrence after bulbar urethroplasty. J Urol. 2018;200(4):837-842. doi:10.1016/j.juro.2018.04.081.

  16. Bandini M, Basile G, Lazzeri M, et al. Optimizing decision-making after ventral onlay buccal mucosa graft urethroplasty failure. BJU Int. 2023;131(3):339-347. doi:10.1111/bju.15895.

  17. European Association of Urology. EAU Guidelines on Urethral Strictures. 2026, section 6.2. Official full guideline. Related guideline summary: Campos-Juanatey F, Barratt R, Chan G, et al. Eur Urol. 2026;90(2):153-162. doi:10.1016/j.eururo.2026.04.021.

  18. Srikanth P, DeLong J, Virasoro R, et al. 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.

  19. American Urological Association. Urethral Stricture Disease: AUA Guideline (published 2016; amended 2023), unabridged version. Guideline.

  20. US Food and Drug Administration. Optilume Urethral Drug Coated Balloon, PMA P210020: Summary of Safety and Effectiveness Data and Instructions for Use (1111-003; the Rev B IFU was checked for the statements cited above on September 26, 2026). FDA SSED.

  21. Lubahn JD, Zhao LC, Scott JF, Hudak SJ, Chee J, Terlecki R, Breyer B, Morey AF. Poor quality of life in patients with urethral stricture treated with intermittent self-dilation. J Urol. 2014;191(1):143-147. doi:10.1016/j.juro.2013.06.054.

  22. Gridley CM. Direct Vision Internal Urethrotomy. In: Smith JA Jr, Dmochowski RR, Thomas JC, Preminger GM, eds. Hinman's Atlas of Urologic Surgery. 5th ed. Elsevier; 2025:759-761.

  23. Geavlete P, Cauni V, Georgescu D. Value of preoperative urethral ultrasound in optic internal urethrotomy. Eur Urol. 2005;47(6):865-871. doi:10.1016/j.eururo.2004.10.019.

  24. Ferguson GG, Bullock TL, Anderson RE, Blalock RE, Brandes SB. Minimally invasive methods for bulbar urethral strictures: a survey of members of the American Urological Association. Urology. 2011;78(3):701-706. doi:10.1016/j.urology.2011.02.051.

  25. Santucci R, Eisenberg L. Urethrotomy has a much lower success rate than previously reported. J Urol. 2010;183(5):1859-1862. doi:10.1016/j.juro.2010.01.020.

  26. Urotronic, Inc. Optilume Urethral Drug Coated Balloon Catheter: Instructions for Use. Document 1111-003 Rev B. Manufacturer PDF.