Optilume Balloon Dilation for Radiation Induced Posterior Urethral Stenosis: A Multi-Institutional Experience

Optilume Balloon Dilation for Radiation Induced Posterior Urethral Stenosis: A Multi-Institutional Experience | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Optilume Balloon Dilation for Radiation Induced Posterior Urethral Stenosis: A Multi-Institutional Experience Brian Ceballos, Eshan Joshi, Kayla Graham, Luke Shumaker, Katherine Englander, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5649049/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 19 Jul, 2025 Read the published version in BMC Urology → Version 1 posted 11 You are reading this latest preprint version Abstract Introduction : Radiation induced urethral stenosis disease represents a complex subset of patients with higher rates of recurrence after treatment. Optilume®, a Paclitaxel drug-coated balloon, has been utilized in anterior urethral strictures with promising results. Although urethroplasty is traditionally regarded as the gold standard for treating radiation-induced posterior urethral stenosis, it can be an invasive and challenging procedure with potential side effects. We aim to evaluate the efficacy of the Optilume® drug-coated balloon as a minimally invasive treatment option for radiation-induced posterior urethral stenosis. Methods : A retrospective, multi-institutional review was conducted on male patients who underwent Optilume® drug-coated balloon dilation from January 1, 2022, to November 1, 2023. The study involved five surgeons across four institutions. Patients were investigated based on their history of radiation-induced posterior urethral stenosis, and comparisons were made regarding demographics, characteristics of urethral stenosis, and outcomes, including surgical success and complications. Results : Among the 56 patients with radiation-induced posterior urethral stenosis evaluated across all four institutions, 37 men had at least 90-day follow-up data. Of these 37 patients, 30 (81.1%) were deemed successful, defined as being free from repeat intervention. Although 6 patients (10.7%) experienced complications, none were greater than Clavien IIIb, with the most common complication being acute urinary retention. Conclusion : Although radiation-induced urethral stenosis is typically associated with high rates of recurrence following conservative treatment, Optilume® drug-coated balloon represents an alternative endoscopic treatment option with encouraging short-term results. Urethral stricture radiation Optilume balloon dilation Figures Figure 1 Introduction Urethral stenosis can be challenging for both patients and providers due to symptomatology and rates of recurrence. Traditional management strategies have included self-dilation, endoscopic treatment (balloon dilation and direct visual internal urethrotomy) as well as urethroplasty. Although urethroplasty is more invasive, its high rate of success in comparison to endoscopic management has supported its role as definitive treatment of recurrent urethral strictures [ 1 , 2 ]. More recently, endoscopic management of anterior urethral strictures with the Optilume® drug-coated balloon (DCB) (Laborie Medical Technologies Corp., Portsmouth, NH) has been studied. FDA approved in 2021 for treatment of patients with obstructive urinary symptoms associated with an anterior urethral stricture, Optilume® is a Paclitaxel coated balloon that has demonstrated encouraging results thus far, with freedom from repeat intervention of 83.2% and 77.8% at 1 and 2 years post-operatively, in comparison to 23.6% of patients treated with standard endoscopic management at 1 year [ 3 , 4 ]. The pathophysiology of radiation-induced urethral stenosis is believed to involve a combination of radiation-induced DNA damage and poor vascularity. This results in urethral tissue damage, causing fibrosis and atrophy due to fibroblast proliferation, which ultimately leads to tissue contraction and stenosis [ 5 – 7 ]. Considering this process, Paclitaxel, a microtubule inhibitor, is thought to be particularly effective in combating fibroblast proliferation. This concept, combined with the mechanical dilation of urethral stenosis, prompted our investigation into the use of the Optilume® DCB) for managing RIPUS. Although radiation therapy is an effective management strategy for prostate cancer, a known potential side effect is urethral stricture [ 5 ]. The incidence of radiation-induced urethral stricture varies by treatment modality, and has been reported to occur in 2% and 4% of patients undergoing external beam radiation and brachytherapy, respectively, with an incidence of 11% in combined therapy [ 8 ]. Additionally, patients with a history of radiation are at high risk of recurrence, with reported incidence of 49% after endoscopic treatment at median 16 months amongst brachytherapy patients [ 9 ]. As such, we aim to report our initial experience using the Optilume® DCB for management of RIPUS. Methods After IRB approval, we conducted a retrospective, multi-institutional review of patients diagnosed with radiation-induced posterior urethral stenosis (RIPUS) via cystoscopy and/or retrograde urethrography (RUG). These patients underwent Optilume® drug-coated balloon (DCB) dilation from January 1, 2022, to November 1, 2023. The procedure was performed by five surgeons across four institutions. Patients with RIPUS were further investigated based on demographics, characteristics of urethral stenosis, and outcomes, including surgical success and complications. Success was defined as freedom from re-intervention in patients with at least three months of follow-up. The exclusion criteria were patients with urethral stenosis anterior to the bulbomembranous urethra. The procedure began with the cystoscopic placement of a 0.038” guidewire. Three of the four centers pre-dilated the stricture with a 24Fr standard balloon before using the 30Fr Optilume® DCB as per the instructions to assess the proximal extent of the stricture and presence of other strictures. The fourth site used retrograde urethrogram to help make this determination. Depending on the length of stenosis (determined either visually or via RUG), either 3 cm or 5 cm Optilume® balloons were used to ensure the entire length of the stenotic segment was treated. The Optilume® balloon was inflated to the specified rated burst pressure (RBP) for 5 minutes, then deflated and removed. The stenotic area was re-evaluated to ensure the cystoscope could easily navigate through the treatment site. Once patency was confirmed, the guidewire was replaced into the bladder, and the cystoscope was removed. A 16Fr Foley catheter was then placed over the wire into the bladder and left in place for a median of 3 days post-operatively (range: 2–4 days). Patients followed up according to each institution’s individualized protocol, with or without a cystoscopy. Results After excluding patients with anterior urethral strictures and identifying patients who developed urethral stenosis following pelvic radiation exposure, 56 men met the inclusion criteria for our study. The average length of stenosis was 1.83 cm (± 0.98 cm) and was located at the bulbomembranous urethra. Pre-dilation was performed in 38 of the 56 patients (67.9%). Among the 56 patients with RIPUS treated, 37 men (66.1%) had at least 90 days of follow-up data. Freedom from repeat intervention was achieved in 30 of the 37 patients (81.8%). Urethral patency, defined as the ability to easily pass a standard 17 Fr flexible cystoscope through the urethra, was observed in 22 of the 29 men (75.9%). Symptomatic recurrence occurred in 9 patients (24.3%). Of the 7 patients who required repeat intervention, this consisted of self-dilation, endoscopic treatment, or urethroplasty. The mean follow-up was 179.4 days (± 134.9 days). Six patients developed complications, most commonly acute urinary retention requiring catheterization. No complication exceeded Clavien Grade IIIb (Fig. 1 ). Discussion Management of RIPUS has been notoriously challenging due to the limited effectiveness of treatment options other than formal urethroplasty. While endoscopic management may provide immediate improvement, it is associated with high rates of recurrence [ 9 ]. Conversely, urethroplasty is considered the gold standard for recurrent or complex urethral strictures. Success rates for urethroplasty in treating radiation-induced urethral strictures range between 70% and 90% [ 5 , 10 , 11 ]. Although these values appear encouraging, urethroplasty for radiation-induced urethral stricture is not a perfect procedure, with repeat intervention reported in 14.3% of patients [ 12 ]. Additionally, in a systematic review of radiation-induced bulbomembranous urethral stenosis by Sapienza and colleagues, post-operative stress urinary incontinence developed in roughly 19% of patients [ 13 ]. Moreover, urethroplasty is not suitable for everyone. Patients are often poor candidates (co-morbid, frail, chronically anticoagulated, unable to sustain prolonged time under anesthesia, etc.) or simply do not desire an invasive repair prompting a search for an alternative, minimally invasive strategy. Strengths of our study are its multi-institutional nature, supporting its generalizability in this niche patient population. The limitations, however, include variations in practice patterns and the lack of a standardized follow-up protocol, which can introduce confounding variables in complications and rates of success. The study also has short-term follow-up and is retrospective in nature, so definitive results on success and complications long term cannot be made. Despite these limitations, our outcomes, provide insight into an alternative, minimally invasive management strategy that appears more effective than traditional endoscopic treatments for RIPUS in the short-term interval. Conclusion Patients with RIPUS present a complex subset of stricture disease characterized by high recurrence rates following traditional endoscopic treatments. While urethroplasty has long been the gold standard for definitive management, its invasiveness and associated potential side effects may limit its suitability for patients with comorbidities. The Optilume® DCB offers a promising, minimally invasive alternative for treating RIPUS, demonstrating encouraging short to intermediate term outcomes. Looking ahead, the role of Optilume® in RIPUS treatment will benefit from further elucidation through long-term data analysis. Declarations Competing Interests Statement: Drs. Morey, VanDyke, Wiegand, and Baumgarten are consultants for Laborie (non-financial). Human Ethics and Consent to Participate Declaration : Informed consent to participate and IRB approval was obtained in accordance with the UAB Ethics Committee and Declaration of Helsinki. Funding Declaration: There was no funding for this manuscript. References Morey AF, et al. SIU/ICUD Consultation on Urethral Strictures: Anterior urethra–primary anastomosis. Urology. 2014;83(3 Suppl):S23–6. Santucci R, Eisenberg L. Urethrotomy has a much lower success rate than previously reported. J Urol. 2010;183(5):1859–62. Elliott SP, et al. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume((R)) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol. 2022;207(4):866–75. VanDyke ME, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2024;5(3):366–73. Hofer MD, Gonzalez CM. Management of radiation-induced urethral strictures. Transl Androl Urol. 2015;4(1):66–71. Luo H, et al. Pharmacotherapy of urethral stricture. Asian J Androl. 2024;26(1):1–9. Park J, Kim SW, Cho MC. The Role of LIM Kinase in the Male Urogenital System. Cells, 2021. 11(1). Mohammed N, et al. Comparison of acute and late toxicities for three modern high-dose radiation treatment techniques for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2012;82(1):204–12. Sullivan L, et al. Urethral stricture following high dose rate brachytherapy for prostate cancer. Radiother Oncol. 2009;91(2):232–6. Hofer MD, et al. Outcomes after urethroplasty for radiotherapy induced bulbomembranous urethral stricture disease. J Urol. 2014;191(5):1307–12. Glass AS, et al. Urethroplasty after radiation therapy for prostate cancer. Urology. 2012;79(6):1402–5. Rourke K, Kinnaird A, Zorn J. Observations and outcomes of urethroplasty for bulbomembranous stenosis after radiation therapy for prostate cancer. World J Urol. 2016;34(3):377–82. Sapienza LG, et al. Efficacy and Incontinence Rates After Urethroplasty for Radiation-induced Urethral Stenosis: A Systematic Review and Meta-analysis. Urology. 2021;152:109–16. Additional Declarations Competing interest reported. Drs. Morey, VanDyke, Wiegand, and Baumgarten are consultants for Laborie (non-financial). Supplementary Files PostXRTOptilumeDataSheet.xlsx STROBEchecklistcohort.docx Cite Share Download PDF Status: Published Journal Publication published 19 Jul, 2025 Read the published version in BMC Urology → Version 1 posted Editorial decision: Revision requested 16 Apr, 2025 Reviews received at journal 15 Apr, 2025 Reviewers agreed at journal 12 Apr, 2025 Reviews received at journal 08 Apr, 2025 Reviews received at journal 07 Apr, 2025 Reviewers agreed at journal 07 Apr, 2025 Reviewers agreed at journal 07 Apr, 2025 Reviewers agreed at journal 07 Apr, 2025 Reviewers invited by journal 07 Apr, 2025 Submission checks completed at journal 07 Apr, 2025 First submitted to journal 06 Apr, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Drs. Morey, VanDyke, Wiegand, and Baumgarten are consultants for Laborie (non-financial).","formattedTitle":"\u003cp\u003eOptilume Balloon Dilation for Radiation Induced Posterior Urethral Stenosis: A Multi-Institutional Experience\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eUrethral stenosis can be challenging for both patients and providers due to symptomatology and rates of recurrence. Traditional management strategies have included self-dilation, endoscopic treatment (balloon dilation and direct visual internal urethrotomy) as well as urethroplasty. Although urethroplasty is more invasive, its high rate of success in comparison to endoscopic management has supported its role as definitive treatment of recurrent urethral strictures [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. More recently, endoscopic management of anterior urethral strictures with the Optilume\u0026reg; drug-coated balloon (DCB) (Laborie Medical Technologies Corp., Portsmouth, NH) has been studied. FDA approved in 2021 for treatment of patients with obstructive urinary symptoms associated with an anterior urethral stricture, Optilume\u0026reg; is a Paclitaxel coated balloon that has demonstrated encouraging results thus far, with freedom from repeat intervention of 83.2% and 77.8% at 1 and 2 years post-operatively, in comparison to 23.6% of patients treated with standard endoscopic management at 1 year [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe pathophysiology of radiation-induced urethral stenosis is believed to involve a combination of radiation-induced DNA damage and poor vascularity. This results in urethral tissue damage, causing fibrosis and atrophy due to fibroblast proliferation, which ultimately leads to tissue contraction and stenosis [\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Considering this process, Paclitaxel, a microtubule inhibitor, is thought to be particularly effective in combating fibroblast proliferation. This concept, combined with the mechanical dilation of urethral stenosis, prompted our investigation into the use of the Optilume\u0026reg; DCB) for managing RIPUS.\u003c/p\u003e \u003cp\u003eAlthough radiation therapy is an effective management strategy for prostate cancer, a known potential side effect is urethral stricture [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The incidence of radiation-induced urethral stricture varies by treatment modality, and has been reported to occur in 2% and 4% of patients undergoing external beam radiation and brachytherapy, respectively, with an incidence of 11% in combined therapy [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Additionally, patients with a history of radiation are at high risk of recurrence, with reported incidence of 49% after endoscopic treatment at median 16 months amongst brachytherapy patients [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. As such, we aim to report our initial experience using the Optilume\u0026reg; DCB for management of RIPUS.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eAfter IRB approval, we conducted a retrospective, multi-institutional review of patients diagnosed with radiation-induced posterior urethral stenosis (RIPUS) via cystoscopy and/or retrograde urethrography (RUG). These patients underwent Optilume\u0026reg; drug-coated balloon (DCB) dilation from January 1, 2022, to November 1, 2023. The procedure was performed by five surgeons across four institutions. Patients with RIPUS were further investigated based on demographics, characteristics of urethral stenosis, and outcomes, including surgical success and complications. Success was defined as freedom from re-intervention in patients with at least three months of follow-up. The exclusion criteria were patients with urethral stenosis anterior to the bulbomembranous urethra.\u003c/p\u003e \u003cp\u003eThe procedure began with the cystoscopic placement of a 0.038\u0026rdquo; guidewire. Three of the four centers pre-dilated the stricture with a 24Fr standard balloon before using the 30Fr Optilume\u0026reg; DCB as per the instructions to assess the proximal extent of the stricture and presence of other strictures. The fourth site used retrograde urethrogram to help make this determination. Depending on the length of stenosis (determined either visually or via RUG), either 3 cm or 5 cm Optilume\u0026reg; balloons were used to ensure the entire length of the stenotic segment was treated. The Optilume\u0026reg; balloon was inflated to the specified rated burst pressure (RBP) for 5 minutes, then deflated and removed. The stenotic area was re-evaluated to ensure the cystoscope could easily navigate through the treatment site. Once patency was confirmed, the guidewire was replaced into the bladder, and the cystoscope was removed. A 16Fr Foley catheter was then placed over the wire into the bladder and left in place for a median of 3 days post-operatively (range: 2\u0026ndash;4 days). Patients followed up according to each institution\u0026rsquo;s individualized protocol, with or without a cystoscopy.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eAfter excluding patients with anterior urethral strictures and identifying patients who developed urethral stenosis following pelvic radiation exposure, 56 men met the inclusion criteria for our study.\u003c/p\u003e\n\u003cp\u003eThe average length of stenosis was 1.83 cm (\u0026plusmn;\u0026thinsp;0.98 cm) and was located at the bulbomembranous urethra. Pre-dilation was performed in 38 of the 56 patients (67.9%).\u003c/p\u003e\n\u003cp\u003eAmong the 56 patients with RIPUS treated, 37 men (66.1%) had at least 90 days of follow-up data. Freedom from repeat intervention was achieved in 30 of the 37 patients (81.8%). Urethral patency, defined as the ability to easily pass a standard 17 Fr flexible cystoscope through the urethra, was observed in 22 of the 29 men (75.9%). Symptomatic recurrence occurred in 9 patients (24.3%). Of the 7 patients who required repeat intervention, this consisted of self-dilation, endoscopic treatment, or urethroplasty. The mean follow-up was 179.4 days (\u0026plusmn;\u0026thinsp;134.9 days). Six patients developed complications, most commonly acute urinary retention requiring catheterization. No complication exceeded Clavien Grade IIIb (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eManagement of RIPUS has been notoriously challenging due to the limited effectiveness of treatment options other than formal urethroplasty. While endoscopic management may provide immediate improvement, it is associated with high rates of recurrence [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Conversely, urethroplasty is considered the gold standard for recurrent or complex urethral strictures. Success rates for urethroplasty in treating radiation-induced urethral strictures range between 70% and 90% [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Although these values appear encouraging, urethroplasty for radiation-induced urethral stricture is not a perfect procedure, with repeat intervention reported in 14.3% of patients [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Additionally, in a systematic review of radiation-induced bulbomembranous urethral stenosis by Sapienza and colleagues, post-operative stress urinary incontinence developed in roughly 19% of patients [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Moreover, urethroplasty is not suitable for everyone. Patients are often poor candidates (co-morbid, frail, chronically anticoagulated, unable to sustain prolonged time under anesthesia, etc.) or simply do not desire an invasive repair prompting a search for an alternative, minimally invasive strategy.\u003c/p\u003e \u003cp\u003eStrengths of our study are its multi-institutional nature, supporting its generalizability in this niche patient population. The limitations, however, include variations in practice patterns and the lack of a standardized follow-up protocol, which can introduce confounding variables in complications and rates of success. The study also has short-term follow-up and is retrospective in nature, so definitive results on success and complications long term cannot be made. Despite these limitations, our outcomes, provide insight into an alternative, minimally invasive management strategy that appears more effective than traditional endoscopic treatments for RIPUS in the short-term interval.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003ePatients with RIPUS present a complex subset of stricture disease characterized by high recurrence rates following traditional endoscopic treatments. While urethroplasty has long been the gold standard for definitive management, its invasiveness and associated potential side effects may limit its suitability for patients with comorbidities. The Optilume\u0026reg; DCB offers a promising, minimally invasive alternative for treating RIPUS, demonstrating encouraging short to intermediate term outcomes. Looking ahead, the role of Optilume\u0026reg; in RIPUS treatment will benefit from further elucidation through long-term data analysis.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCompeting Interests Statement:\u003c/strong\u003e Drs. Morey, VanDyke, Wiegand, and Baumgarten are consultants for Laborie (non-financial).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHuman Ethics and Consent to Participate Declaration\u003c/strong\u003e: Informed consent to participate and IRB approval was obtained in accordance with the UAB Ethics Committee and Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Declaration:\u0026nbsp;\u003c/strong\u003eThere was no funding for this manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMorey AF, et al. SIU/ICUD Consultation on Urethral Strictures: Anterior urethra\u0026ndash;primary anastomosis. Urology. 2014;83(3 Suppl):S23\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSantucci R, Eisenberg L. Urethrotomy has a much lower success rate than previously reported. J Urol. 2010;183(5):1859\u0026ndash;62.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eElliott SP, et al. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume((R)) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol. 2022;207(4):866\u0026ndash;75.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVanDyke ME, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2024;5(3):366\u0026ndash;73.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHofer MD, Gonzalez CM. Management of radiation-induced urethral strictures. Transl Androl Urol. 2015;4(1):66\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLuo H, et al. Pharmacotherapy of urethral stricture. Asian J Androl. 2024;26(1):1\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePark J, Kim SW, Cho MC. The Role of LIM Kinase in the Male Urogenital System. Cells, 2021. 11(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMohammed N, et al. Comparison of acute and late toxicities for three modern high-dose radiation treatment techniques for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2012;82(1):204\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSullivan L, et al. Urethral stricture following high dose rate brachytherapy for prostate cancer. Radiother Oncol. 2009;91(2):232\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHofer MD, et al. Outcomes after urethroplasty for radiotherapy induced bulbomembranous urethral stricture disease. J Urol. 2014;191(5):1307\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGlass AS, et al. Urethroplasty after radiation therapy for prostate cancer. Urology. 2012;79(6):1402\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRourke K, Kinnaird A, Zorn J. Observations and outcomes of urethroplasty for bulbomembranous stenosis after radiation therapy for prostate cancer. World J Urol. 2016;34(3):377\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSapienza LG, et al. Efficacy and Incontinence Rates After Urethroplasty for Radiation-induced Urethral Stenosis: A Systematic Review and Meta-analysis. Urology. 2021;152:109\u0026ndash;16.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"buro","sideBox":"Learn more about [BMC Urology](http://bmcurol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/buro/default.aspx","title":"BMC Urology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Urethral stricture, radiation, Optilume, balloon dilation","lastPublishedDoi":"10.21203/rs.3.rs-5649049/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5649049/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e: Radiation induced urethral stenosis disease represents a complex subset of patients with higher rates of recurrence after treatment. Optilume®, a Paclitaxel drug-coated balloon, has been utilized in anterior urethral strictures with promising results. Although urethroplasty is traditionally regarded as the gold standard for treating radiation-induced posterior urethral stenosis, it can be an invasive and challenging procedure with potential side effects. We aim to evaluate the efficacy of the Optilume® drug-coated balloon as a minimally invasive treatment option for radiation-induced posterior urethral stenosis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: A retrospective, multi-institutional review was conducted on male patients who underwent Optilume® drug-coated balloon dilation from January 1, 2022, to November 1, 2023. The study involved five surgeons across four institutions. Patients were investigated based on their history of radiation-induced posterior urethral stenosis, and comparisons were made regarding demographics, characteristics of urethral stenosis, and outcomes, including surgical success and complications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Among the 56 patients with radiation-induced posterior urethral stenosis evaluated across all four institutions, 37 men had at least 90-day follow-up data. Of these 37 patients, 30 (81.1%) were deemed successful, defined as being free from repeat intervention. Although 6 patients (10.7%) experienced complications, none were greater than Clavien IIIb, with the most common complication being acute urinary retention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: Although radiation-induced urethral stenosis is typically associated with high rates of recurrence following conservative treatment, Optilume® drug-coated balloon represents an alternative endoscopic treatment option with encouraging short-term results.\u003c/p\u003e","manuscriptTitle":"Optilume Balloon Dilation for Radiation Induced Posterior Urethral Stenosis: A Multi-Institutional Experience","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-10 06:19:21","doi":"10.21203/rs.3.rs-5649049/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-04-16T13:07:36+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-15T20:48:47+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"273970873020109432041475211976599477639","date":"2025-04-12T19:14:05+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-08T14:25:15+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-07T19:28:07+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"278911728968758322006865390851231610624","date":"2025-04-07T19:14:03+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"71019443823385738476501745523170505221","date":"2025-04-07T18:39:26+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"48782188162892047281191264253040881990","date":"2025-04-07T17:56:12+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-07T17:52:18+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-04-07T12:29:17+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Urology","date":"2025-04-06T20:33:30+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"buro","sideBox":"Learn more about [BMC Urology](http://bmcurol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/buro/default.aspx","title":"BMC Urology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1f5eea60-23b8-475b-96dc-e369bf681c14","owner":[],"postedDate":"April 10th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-08-07T07:12:52+00:00","versionOfRecord":{"articleIdentity":"rs-5649049","link":"https://doi.org/10.1186/s12894-025-01829-0","journal":{"identity":"bmc-urology","isVorOnly":false,"title":"BMC Urology"},"publishedOn":"2025-07-19 16:05:42","publishedOnDateReadable":"July 19th, 2025"},"versionCreatedAt":"2025-04-10 06:19:21","video":"","vorDoi":"10.1186/s12894-025-01829-0","vorDoiUrl":"https://doi.org/10.1186/s12894-025-01829-0","workflowStages":[]},"version":"v1","identity":"rs-5649049","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5649049","identity":"rs-5649049","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}