Outcomes of patients undergoing Optilume® drug-coated balloon for different locations of urethral strictures: results from a multicenter cohort

Outcomes of patients undergoing Optilume® drug-coated balloon for different locations of urethral strictures: results from a multicenter cohort | 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 Outcomes of patients undergoing Optilume® drug-coated balloon for different locations of urethral strictures: results from a multicenter cohort Lea Seiler, Giovanni Lorenzo De Giorgi, Guglielmo Mantica, Leonidas Karapanos, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9398079/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 9 You are reading this latest preprint version Abstract Introduction & Objectives: The Optilume® drug-coated balloon (DCB), combining mechanical dilation with localized paclitaxel delivery, is a novel minimally invasive treatment for urethral stricture disease. However, data on its effectiveness across different stricture locations are limited. This study evaluates functional outcomes following treatment for different strictures locations. Materials & Methods: This retrospective multicenter study included patients treated with Optilume® DCB for urethral strictures at five European tertiary care referral centers (June 2023 - June 2025). Stricture length was assessed by retrograde urethrography, cystoscopy, or both. Recurrence was defined as any symptomatic stricture requiring treatment. A multivariable logistic regression using preoperative data was developed to predict recurrence requiring treatment. Results: In total 86 patients were included across four stricture locations: penile (n = 11, 13%), bulbar/penobulbar (n = 59, 68%), bulbomembranous/membranous (n = 13, 15%) and bladder neck (n = 3, 4%). Postoperative complications within 30 days occurred in 5 (5.8%) patients. Median follow-up duration ranged from 3 to 11 months. Median peak urinary flow increased from 3.5–8.8 mL/s preoperatively to 13.5–19 mL/s at 3 months. Stricture-free rates were highest in penile (91%) and bladder neck (100%) strictures, and lower for bulbar (74%) and bulbomembranous/membranous (69%) strictures. On multivariate logistic regression analysis, diabetes was an independent predictor of stricture recurrence (OR = 7.66, 95% CI 1.55–47.12, p = 0.01). Conclusions: Optilume® DCB showed encouraging efficacy and safety across different urethral stricture locations, achieving high stricture-free rates and improved urinary flow. Diabetes independently predicted recurrence, highlighting the value of optimizing modifiable risk factors. Balloon-dilatation Optilume Urethral stricture Outcomes Introduction Urethral stricture disease poses a significant therapeutic challenge in the clinical practice for urologists around the world due to the high likelihood of recurrence following conventional endoscopic management ( 1 ). Endoscopic treatment options, which are routinely used, like mechanical dilatation and direct vision internal urethrotomy (DVIU), have variable success rates, with reported patency rates between 8–77% ( 2 – 4 ). The gold standard for the management of anterior urethral stricture in men still is urethroplasty, with recurrence rates of approximately 15% ( 5 ). As urethroplasty is more invasive and requires longer hospital admission, as well as greater associated risk profile and longer catheterization period ( 6 ), minimally invasive techniques are often preferred as a first step of treatment strategy. The Optilume® drug-coated balloon (DCB) is new minimally invasive treatment option, combining mechanical dilation with localized paclitaxel delivery. This is the first DCB intended for use in male urethral strictures ( 7 , 8 ). The procedure can be conducted in an outpatient setting, whereby the balloon first dilating the affected area then circumferentially delivers the antiproliferative drug Paclitaxel, which inhibits smooth muscle cell proliferation and collagen production leading to reduced fibrosis ( 9 ). Data on the effectiveness of Optilume® DCB across different stricture types and anatomical locations remain limited. This retrospective cohort study aimed to present the outcomes of patients treated with Optilume® for different types and locations of urethral stricture. Material and Methods Study design We conducted a retrospective, multicenter study including data of patients treated with Optilume® DCB for anterior and posterior urethral strictures between June 2023 and June 2025 at five European tertiary care referral centers. Prior to data collection and analysis, ethical committee approval was given (BASEC 2025 − 01438). All patients included gave informed consent for anonymized data use. Patient characteristics Baseline patients’ characteristics included age at surgery, smoking history and diabetes mellitus status. For urethral stricture disease, the type and length of stricture was classified, as well as any type of previous treatment. If there was previous treatment, the number of prior dilatations or radiation was recorded. Evaluation of stricture length was conducted by retrograde urethrography or cystoscopy, or both combined. Intervention and follow-up Intervention and follow-up The Optilume® treatment was performed according to the centers protocol by trained physicians, either under general or regional anesthesia. Cystoscopically, a guidewire was placed across the stricture into the bladder under radiographic control. The following wire-guided DCB device inflation was performed at 10 atmosphere (atm) for 7 minutes. Postoperatively a catheter was placed for up to three days. The follow-up plan was determined by the treating physician. During follow-up recurrence was detected if there was symptomatic stricture in need of any sort of treatment. Outcomes The primary endpoint of this study was symptomatic stricture recurrence during follow-up. Secondary endpoints were identifying factors leading to a higher risk of stricture recurrence, as well as treatment associated adverse events. Postoperative complications were detected by the treating physician during follow-up visits. Functional outcome was measured before treatment and during follow-up evaluating peak urinary flow (Qmax) and International Prostate Symptom Score (IPSS). Statistical analysis Categorical data was reported as absolute numbers and percentages. Continuous data, depending on their distribution, was reported as means and standard deviations (SD) or medians and interquartile ranges (IQR). Categorical variables were compared between groups using Kruskall-Wallis test. Continuous variables were compared between groups using One-way Anova. Multivariable logistic regression was used to identify factors predicting stricture recurrence. Statistical analysis was performed using R version 4.5.1 (R project, Vienna, Austria). Results Baseline characteristics Baseline demographic and clinical characteristics are displayed in Table 1 . A total of 86 patients treated with Optilume DCB were included across four stricture locations: penile (n = 11, 13%), bulbar/penobulbar (n = 11, 13%), bulbomembranous/membranous (n = 13, 15%) and bladder neck (n = 3, 4%). The median age of patients was 57 (IQR 44–64) and 58 (IQR 46–71) for those with penile and bulbar/penobulbar strictures, respectively, whereas for those with bulbomembranous/membranous and bladder neck strictures it was 74 (IQR 65–76) and 75 (IQR 72–78), respectively. Median stricture length ranged from 1 to 2 cm across groups, with no significant differences observed. Most strictures were idiopathic or iatrogenic in aetiology for all stricture types. The majority of patients had undergone prior stricture treatment, most commonly endoscopic dilation or internal urethrotomy. There were no statistically significant differences between diabetes (p = 1) and smoking history (p = 0.6) across all groups. Table 1 Baseline characteristics of patients treated with Optilume® drug-coated balloon for the management of urethral strictures. Variable Penile (N = 11) Bulbar/Penobulbar (N = 59) Bulbomembranous/ Membranous (N = 13) Bladder neck (N = 3) P-value Age at surgery [years], median (IQR) 57 (44–64) 58 (46–71) 74 (65–76) 75 (72–78) 0.04 Diabetes mellitus, n (%) 2 (18.2) 12 (20.3) 2 (15.4) - 1 Smoking history, n (%) No 10 (90.9) 46 (78.0) 9 (69.2) 2 (66.7) 0.6 Ex smoker 1 (9.1) 10 (16.9) 4 (30.8) 1 (33.3) Active smoker - 3 (5.1%) - - Type of stricture, n(%) Idiopathic 5 (45.5) 27 (45.8) 3 (23.1) - 0.2 Iatrogenic 5 (45.5) 25 (42.4) 8 (61.5) 3 (100) Post-traumatic - 5 (8.5) - - Inflammatory 1 (9.1) 1 (1.7) - - Post-radiotherapy - 1 (1.7) 2 (15.4) - Previous stricture treatment, n(%) 9 (81.8) 45 (76.3) 11 (84.6) 1 (33.3) 0.3 Type of previous treatment, n(%) Only dilatations 3 (27.3) 9 (15.3) 7 (53.8) 1 (33.3) 0.006 Internal urethrotomy +/- dilatations 0 (0) 20 (33.9) 1 (7.7) 0 (0) End-to-end urethroplasty 0 (0) 1 (1.7) 0 (0) 0 (0) Buccal mucosal urethroplasty 6 (54.5) 15 (25.4) 3 (23.1) 0 (0) Missing 2 (18.2) 14 (23.7) 2 (15.4) 2 (66.7) Prior pelvic radiation, n(%) 0 (0) 3 (5.1) 2 (15.4) 0 (0) 0.4 Prior dilations, n(%) 6 (54.5) 19 (32.2) 11 (84.6) 1 (33.3) 0.003 Number of prior dilations, median (IQR) 1 ( 1 – 1 ) 2 ( 1 – 3 ) 4 ( 1 – 10 ) - 0.2 Stricture length [cm], median (IQR) 2 ( 1 – 3 ) 1 ( 1 – 2 ) 2 ( 1 – 3 ) 1 ( 1 – 1 ) 0.1 Functional outcome Comparison of pre- and postoperative functional outcome is displayed in Table 3 . Median Qmax increased from 3.5–8.8 mL/s preoperatively to 13.5–19 mL/s at 3 months over all groups. The median IPSS was assessed before and after surgery for all stricture types except blader neck strictures. IPSS decreased after treatment for all groups, with a decrease from 8 (IQR = 8–8) to 1.5 (IQR = 1–2) for penile strictures, 15 (IQR = 11–24) to 5 (IQR = 3–9) for bulbar/penobulbar strictures and 22 (IQR = 19–26) to 5 (IQR = 3–7) for bulbomembranous/membranous strictures. Table 3 Comparison of preoperative and postoperative functional outcomes of patients treated with Optilume® drug-coated balloon for the management of urethral strictures. Peak urinary flow (Qmax) before surgery [ml/s], median (IQR) Penile (N = 11) Bulbar/ Penobulbar (N = 59) Bulbomembranous/ Membranous (N = 13) Bladder neck (N = 3) P-value 3 ( 3 – 5 ) 7 ( 5 – 10 ) 9 ( 4 – 12 ) 5 ( 5 – 5 ) 0.3 Post-void residual (PVR) before surgery [ml], median (IQR) 13 (0–46) 78 (30–196) 0 (0–45) 0 (0–0) 0.1 IPSS before surgery [0–35], median (IQR) 8 ( 8 – 8 ) 15.0 (11–24) 22 (19–26) - 0.2 Peak urinary flow (Qmax) at 3 months [ml/s], median (IQR) 13 (12–20) 19 (15–25) 18.8 (17–21) 18 (15–21) 0.7 Post-void residual (PVR) at 3 months [ml], median (IQR) 0 (0–12) 20 (0–50) 0 (0–5) 50 (25–75) 0.3 IPSS at 3 months [0–35], median (IQR) 1 ( 1 – 2 ) 5 ( 3 – 9 ) 5 ( 3 – 7 ) - 0.2 Stricture-free survival Median follow-up duration ranged from 3 to 11 months depending on stricture location. Stricture free survival for different types of urethral stricture is displayed in Table 4 . Stricture persistence was observed in 20 (23%) patients, with no persistence among bladder neck strictures. Stricture persistence was most frequently observed in patients with bulbomembranous/membranous strictures (30.8%, n = 4), followed by bulbar/penobulbar (25.4%, n = 15) and penile strictures (9.1%, n = 1). There was no significant difference between persisting stricture during follow-up for the different types of urethral stricture (p = 0.5). Table 4 Stricture-free survival of patients undergoing Optilume® DCB for different types of urethral stricture. Months of follow-up [months], median (IQR) Penile (N = 11) Bulbar/Penobulbar (N = 59) Bulbomembranous/ Membranous (N = 13) Bladder neck (N = 3) P-value 3 ( 1 – 6 ) 5 ( 3 – 7 ) 9 ( 6 – 13 ) 10 ( 10 – 11 ) 0.07 Persisting stricture during follow-up, n(%) 1 (9.1) 15 (25.4) 4 (30.8) 0 0.5 Postoperative complications Postoperative data is displayed in Table 2 . Postoperative complications within 30 days occurred in 5 (5.8%) patients. 3 patients (5.1%) with bulbar/penobulbar stricture and 2 patients (15.4%) with bulbomembranous/membranous stricture without a significant difference between them (p = 0.4). There were no postoperative complications detected for patients treated with penile or bladder neck strictures. Table 2 Postoperative data of patients treated with Optilume® drug-coated balloon for the management of urethral strictures. Postoperative complications within 30 days, n(%) Penile (N = 11) Bulbar/ Penobulbar (N = 59) Bulbomembranous/ Membranous (N = 13) Bladder neck (N = 3) P-value - 3 (5.1) 2 (15.4) - 0.4 Length of indwelling urethral catheter [days], median (IQR) 0 (0–0.5) 2 (0–3) 1 (0–2) 0 0.02 Months of follow-up [months], median (IQR) 3 ( 1 – 6 ) 5 ( 3 – 7 ) 9.5 ( 6 – 13 ) 10.5 ( 10 – 11 ) Persisting stricture during follow-up, n(%) 1 (9.1) 15 (25.4) 4 (30.8) 0 0.5 Factors predictive of stricture recurrence Factors predicting stricture recurrence are displayed in Table 5 . On multivariate logistic regression analysis, diabetes was the only independent predictor of symptomatic stricture recurrence (OR = 7.66, 95% CI 1.55–47.12, p = 0.01). Table 5 Multivariable logistic regression predicting stricture during follow up. Variable Odds Ratio (95% CI) p-value Age 1 (0.97–1.04) 0.8 Diabetes 7.66 (1.55–47.12) 0.01 Smoking 0.48 (0.12–1.5) 0.2 Stricture site 5.35 (0.74–115) 0.1 Prior radiation therapy 1.02 (0.08–13.74) 0.9 Discussion In our multicentre, retrospective study we provide real-world data on effectiveness and functional outcomes of Optilume® DCB treatment of urethral stricture according to stricture location. Our results show favourable short- and mid-term results regarding stricture free rate and safety profile for all stricture locations. In our patient cohort, stricture-free rate during follow-up was the highest for bladder neck stricture, with no recurrence occurring, followed by penile strictures, bulbar/penobulbar and lastly bulbomembranous/membranous strictures. The follow-up time was variable between the groups ranging from 3 months to 13 months. Functional outcomes, assessed by IPSS and Qmax before and after surgery, demonstrated symptom reduction and improvement in peak urinary flow across all stricture type groups. The rate of postoperative complications within 30 days after surgery was low with a total of 5 patients (5.8%) experiencing complications. In line with the current literature our data supports the high safety profile of Optilume® treatment across different stricture types. Our study adds valuable real-word data for not only anterior urethral strictures but also posterior stricture types such as bulbomembranous/membranous and bladder neck strictures. As the recommendation for Optilume® use nowadays mainly relies on the results of the ROBUST III study, presenting a 83% stricture free rate for short anterior urethral strictures after 1 year ( 11 ), it is important to further investigate the effectiveness of Optilume® for also posterior urethral stricture disease to extend the use of application. Although only 3 patients in total were included in our analysis with bladder neck stricture, reducing the generalizability due to low patient count, it is notable that none of these patients developed a stricture recurrence, suggesting that patient with bladder neck stricture might benefit from Optilume® DCB treatment. These findings are in line with the results of Tosev et al. who reported a no stricture recurrence for their 16 patients with bladder neck stenosis and vesicourethral anastomosis stenosis treated with Optilume® DCB after 12 months ( 12 ). Patients in our cohort with posterior urethral strictures were older than those with anterior strictures, with a median age of 74 years in the bulbomembranous/membranous group and 75 years in the bladder neck group. Given the greater comorbidity burden often associated with advanced age, minimally invasive approaches such as Optilume® may be particularly beneficial in this population. However, in a single-centre retrospective study, Karanjia et el. found no significant association between age and treatment failure after Optilume® treatment, suggesting that advanced age alone may not negatively impact treatment outcome ( 13 ). Thus, elderly patients may benefit from this minimally invasive, which can also be performed under local anaesthesia. To optimize patient selection for different treatment modalities it is essential to look at comorbidities that could influence treatment effectiveness and functional outcome. On multivariant logistic regression analysis, diabetes was the only independent predictor of symptomatic stricture recurrence in our patient cohort. Diabetes mellitus is known to negatively influence wound healing due to impaired microvascular circulation, as well as promoting hypertrophic scar formation ( 14 ), which may plausibly contribute to recurrent urethral fibrosis and reduce treatment success following Optilume® treatment. Given the importance of appropriate patient selection and individualized patient consulting, it is important that further studies evaluate the influence of comorbidities on treatment success. This study has several limitations, which need to be acknowledged. The retrospective design of this study is a limitation itself leading to selection bias. Furthermore, the variability of the follow-up time between stricture type groups, ranging from 3 to 13 months, needs to be addressed because it limits comparability for stricture-free rates. In addition, the relatively short follow-up time in some stricture type groups only allows assessment of short-term outcomes so that conclusions regarding durability of treatment effects cannot be made. Moreover, the evaluation of stricture recurrence was defined as any symptomatic stricture in need of re-treatment, which may lead to underestimation of stricture recurrence due to the lack of cystoscopic confirmation. Despite these limitations, our study adds important real-world data on the effectiveness and safety of Optilume® DCB dilatation for different stricture types as well as looking at factors influencing stricture recurrence. Conclusion Optilume® DCB showed encouraging efficacy and safety across different urethral stricture sites, achieving high stricture-free rates and improved urinary flow. Diabetes was the only factor independently associated with recurrence, highlighting the value of optimizing patient selection and individualized consultation. In the future larger, prospective, long-term studies are needed to validate these findings and define ideal candidates for Optilume® treatment. Declarations Conflict of Interest : The authors declare that they have no conflict of interest. Statement of human rights All persons gave their informed consent to use their data (deidentified). Compliance with Ethical Standards: Ethical committee approval was given (BASEC 2025 − 01438). Funding: No funding was received for this study. Authors Contribution Seiler Manuscript writing and editing, Data management De Giorgi Other (reviewing and editing) Mantica Other (reviewing and editing) Karapanos Other (reviewing and editing) Viktorin Other (reviewing and editing) Ahmed Other (reviewing and editing) Clements Other (reviewing and editing) Güdemann Other (reviewing and editing) Jonusaite Other (reviewing and editing) Gerritsen Other (reviewing and editing) Subotic Other (reviewing and editing) Kwiatkowski Other (reviewing and editing) Sauer Other (reviewing and editing) Wyler Other (supervision, reviewing and editing) Afferi Protocol/project development, Manuscript editing, Data analysis, Data collection and management, Other (supervision) Data Availability The data supporting the findings of this study are not publicly available due to patient privacy and institutional restrictions. De-identified data may be made available from the corresponding author upon reasonable request and with permission of the participating institutions. References Hampson LA, McAninch JW, Breyer BN (2014) Male urethral strictures and their management. Nat Rev Urol 11(1):43–50 Yuruk E, Yentur S, Cakir OO, Ertas K, Serefoglu EC, Semercioz A (2016) Catheter dwell time and diameter affect the recurrence rates after internal urethrotomy. Turk J Urol 42(3):184–189 Al Taweel W, Seyam R (2015) Visual Internal Urethrotomy for Adult Male Urethral Stricture Has Poor Long-Term Results. Adv Urol 2015:656459 Kluth LA, Ernst L, Vetterlein MW, Meyer CP, Reiss CP, Fisch M et al (2017) Direct Vision Internal Urethrotomy for Short Anterior Urethral Strictures and Beyond: Success Rates, Predictors of Treatment Failure, and Recurrence Management. Urology 106:210–215 Meeks JJ, Erickson BA, Granieri MA, Gonzalez CM (2009) Stricture recurrence after urethroplasty: a systematic review. J Urol 182(4):1266–1270 Shen J, Vale L, Goulao B, Whybrow P, Payne S, Watkin N et al (2021) Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis. BMC Urol 21(1):76 Gauhar V, Yuen SKK, Gadzhiev N, Wroclawski M, Pirola GM, Lim EJ et al (2025) Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review. BMC Urol 25(1):196 Alhamdani Z, Ong S, Zhong W, Chin P (2024) Optilume((R)) Drug-Coated Balloon May Lower the Re-Treatment Rate Postintervention for Challenging Urethral Stricture Disease in Long-Term Follow-Up: A Prospective Cohort Study. J Endourol 38(11):1192–1200 Will TA, Polcari AJ, Garcia JG, Ouwenga MK, Voelzke BB, Greisler HP et al (2011) Paclitaxel Inhibits Ureteral Smooth Muscle Cell Proliferation and Collagen Production in the Absence of Cell Toxicity. J Urol 185(1):335–340 Srikanth P, DeLong J, Virasoro R, Elliott SP (2025) A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST III Study. J Endourol 39(9):968–974 Elliott SP, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Carrier S et al (2022) One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume((R)) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol 207(4):866–875 Tosev G, Damgov I, Kuehhas F, Borgmann H, Struck J, Salem J et al (2025) Off-label Use of the Optilume Drug-coated Balloon in the Treatment of Bladder Neck Stenosis and Vesicourethral Anastomosis Stenosis. Eur Urol Open Sci 75:101–105 Karanjia R, Pineda-Turner A, Watts I, Whiting D, Chetwood A (2025) Optilume(R) Balloon Dilatation for Urethral Stricture Disease: An Institutional Review of Outcomes for Multiple Stricture Aetiologies and Characteristics. Cureus 17(9):e91919 Zheng W, Lai W, Zhang Y, Wang X, Yang K, Zhou X et al (2025) Type 2 diabetes as a risk factor for promoting hypertrophic scar formation after wound healing: a two-sample mendelian randomization study. Arch Dermatol Res 317(1):656 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Revision Version 1 posted Editorial decision: Revision requested 01 May, 2026 Reviews received at journal 30 Apr, 2026 Reviewers agreed at journal 24 Apr, 2026 Reviews received at journal 22 Apr, 2026 Reviewers agreed at journal 21 Apr, 2026 Reviewers invited by journal 21 Apr, 2026 Editor assigned by journal 21 Apr, 2026 Submission checks completed at journal 21 Apr, 2026 First submitted to journal 12 Apr, 2026 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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Aarau","correspondingAuthor":false,"prefix":"","firstName":"Stephen","middleName":"","lastName":"Wyler","suffix":""},{"id":629000224,"identity":"018a8140-1f05-4fa3-83b2-87d9af975664","order_by":14,"name":"Luca Afferi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA50lEQVRIiWNgGAWjYBACPgglx8/AwNj4AMji4SOkhQ1CGUs2MDA2G4C0sJGghYFNAkkEjxaJ5IcfGGoMJPilD7dVfs2xk2FjYH746AZeLWnGEgzHDCQk+xLbbstuSwY6jM3YOAevlhwGCQa2P3UGZxjbbktuYwZq4WGTJqCF+QfDPwMJe6CWYslt9URpYZNgbDOQMOBhbGP8uO0wEVp4nplZJPYZSEicYWyWZtx2nIeNmYBf+NmTH9/48A0YYj3sDz/+3FZtz8/e/PAxPi1gkAClmXnAJCHlyIDxBymqR8EoGAWjYMQAAJT5OiHD8AiRAAAAAElFTkSuQmCC","orcid":"","institution":"Kantonsspital Aarau","correspondingAuthor":true,"prefix":"","firstName":"Luca","middleName":"","lastName":"Afferi","suffix":""}],"badges":[],"createdAt":"2026-04-13 03:23:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9398079/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9398079/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":108491975,"identity":"66f798df-74f6-4de3-a041-d4d4f2858653","added_by":"auto","created_at":"2026-05-05 09:56:27","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":341607,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9398079/v1/8d94ab99-5dfb-478c-ae6b-0a052d04420c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Outcomes of patients undergoing Optilume® drug-coated balloon for different locations of urethral strictures: results from a multicenter cohort","fulltext":[{"header":"Introduction","content":"\u003cp\u003eUrethral stricture disease poses a significant therapeutic challenge in the clinical practice for urologists around the world due to the high likelihood of recurrence following conventional endoscopic management (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Endoscopic treatment options, which are routinely used, like mechanical dilatation and direct vision internal urethrotomy (DVIU), have variable success rates, with reported patency rates between 8\u0026ndash;77% (\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). The gold standard for the management of anterior urethral stricture in men still is urethroplasty, with recurrence rates of approximately 15% (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAs urethroplasty is more invasive and requires longer hospital admission, as well as greater associated risk profile and longer catheterization period (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e), minimally invasive techniques are often preferred as a first step of treatment strategy. The Optilume\u0026reg; drug-coated balloon (DCB) is new minimally invasive treatment option, combining mechanical dilation with localized paclitaxel delivery. This is the first DCB intended for use in male urethral strictures (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). The procedure can be conducted in an outpatient setting, whereby the balloon first dilating the affected area then circumferentially delivers the antiproliferative drug Paclitaxel, which inhibits smooth muscle cell proliferation and collagen production leading to reduced fibrosis (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eData on the effectiveness of Optilume\u0026reg; DCB across different stricture types and anatomical locations remain limited. This retrospective cohort study aimed to present the outcomes of patients treated with Optilume\u0026reg; for different types and locations of urethral stricture.\u003c/p\u003e"},{"header":"Material and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003e We conducted a retrospective, multicenter study including data of patients treated with Optilume\u0026reg; DCB for anterior and posterior urethral strictures between June 2023 and June 2025 at five European tertiary care referral centers. Prior to data collection and analysis, ethical committee approval was given (BASEC 2025\u0026thinsp;\u0026minus;\u0026thinsp;01438). All patients included gave informed consent for anonymized data use.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePatient characteristics\u003c/h3\u003e\n\u003cp\u003eBaseline patients\u0026rsquo; characteristics included age at surgery, smoking history and diabetes mellitus status. For urethral stricture disease, the type and length of stricture was classified, as well as any type of previous treatment. If there was previous treatment, the number of prior dilatations or radiation was recorded. Evaluation of stricture length was conducted by retrograde urethrography or cystoscopy, or both combined.\u003c/p\u003e\n\u003ch3\u003eIntervention and follow-up\u003c/h3\u003e\n\u003cdiv class=\"Heading\"\u003eIntervention and follow-up\u003c/div\u003e \u003cp\u003eThe Optilume\u0026reg; treatment was performed according to the centers protocol by trained physicians, either under general or regional anesthesia. Cystoscopically, a guidewire was placed across the stricture into the bladder under radiographic control. The following wire-guided DCB device inflation was performed at 10 atmosphere (atm) for 7 minutes. Postoperatively a catheter was placed for up to three days. The follow-up plan was determined by the treating physician. During follow-up recurrence was detected if there was symptomatic stricture in need of any sort of treatment.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe primary endpoint of this study was symptomatic stricture recurrence during follow-up. Secondary endpoints were identifying factors leading to a higher risk of stricture recurrence, as well as treatment associated adverse events. Postoperative complications were detected by the treating physician during follow-up visits. Functional outcome was measured before treatment and during follow-up evaluating peak urinary flow (Qmax) and International Prostate Symptom Score (IPSS).\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eCategorical data was reported as absolute numbers and percentages. Continuous data, depending on their distribution, was reported as means and standard deviations (SD) or medians and interquartile ranges (IQR). Categorical variables were compared between groups using Kruskall-Wallis test. Continuous variables were compared between groups using One-way Anova. Multivariable logistic regression was used to identify factors predicting stricture recurrence. Statistical analysis was performed using R version 4.5.1 (R project, Vienna, Austria).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eBaseline characteristics\u003c/h2\u003e \u003cp\u003eBaseline demographic and clinical characteristics are displayed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. A total of 86 patients treated with Optilume DCB were included across four stricture locations: penile (n\u0026thinsp;=\u0026thinsp;11, 13%), bulbar/penobulbar (n\u0026thinsp;=\u0026thinsp;11, 13%), bulbomembranous/membranous (n\u0026thinsp;=\u0026thinsp;13, 15%) and bladder neck (n\u0026thinsp;=\u0026thinsp;3, 4%). The median age of patients was 57 (IQR 44\u0026ndash;64) and 58 (IQR 46\u0026ndash;71) for those with penile and bulbar/penobulbar strictures, respectively, whereas for those with bulbomembranous/membranous and bladder neck strictures it was 74 (IQR 65\u0026ndash;76) and 75 (IQR 72\u0026ndash;78), respectively. Median stricture length ranged from 1 to 2 cm across groups, with no significant differences observed. Most strictures were idiopathic or iatrogenic in aetiology for all stricture types. The majority of patients had undergone prior stricture treatment, most commonly endoscopic dilation or internal urethrotomy. There were no statistically significant differences between diabetes (p\u0026thinsp;=\u0026thinsp;1) and smoking history (p\u0026thinsp;=\u0026thinsp;0.6) across all groups.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline characteristics of patients treated with Optilume\u0026reg; drug-coated balloon for the management of urethral strictures.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePenile\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBulbar/Penobulbar\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;59)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBulbomembranous/ Membranous\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;13)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBladder neck\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge at surgery [years], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57 (44\u0026ndash;64)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e58 (46\u0026ndash;71)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e74 (65\u0026ndash;76)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e75 (72\u0026ndash;78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes mellitus, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (18.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (20.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (15.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSmoking history, n (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (90.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46 (78.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (69.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEx smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (16.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (30.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActive smoker\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (5.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eType of stricture, n(%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIdiopathic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (45.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27 (45.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (23.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIatrogenic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (45.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (42.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (61.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-traumatic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (8.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInflammatory\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-radiotherapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (15.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePrevious stricture treatment, n(%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (81.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45 (76.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11 (84.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eType of previous treatment, n(%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOnly dilatations\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (27.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (15.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (53.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.006\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInternal urethrotomy +/- dilatations\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (33.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (7.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnd-to-end urethroplasty\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBuccal mucosal urethroplasty\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (54.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (25.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (23.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMissing\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (18.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (23.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (15.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrior pelvic radiation, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (5.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (15.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrior dilations, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (54.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19 (32.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11 (84.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.003\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber of prior dilations, median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (\u003cspan additionalcitationids=\"CR2 CR3 CR4 CR5 CR6 CR7 CR8 CR9\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStricture length [cm], median (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eFunctional outcome\u003c/h3\u003e\n\u003cp\u003eComparison of pre- and postoperative functional outcome is displayed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e3\u003c/span\u003e. Median Qmax increased from 3.5\u0026ndash;8.8 mL/s preoperatively to 13.5\u0026ndash;19 mL/s at 3 months over all groups. The median IPSS was assessed before and after surgery for all stricture types except blader neck strictures. IPSS decreased after treatment for all groups, with a decrease from 8 (IQR\u0026thinsp;=\u0026thinsp;8\u0026ndash;8) to 1.5 (IQR\u0026thinsp;=\u0026thinsp;1\u0026ndash;2) for penile strictures, 15 (IQR\u0026thinsp;=\u0026thinsp;11\u0026ndash;24) to 5 (IQR\u0026thinsp;=\u0026thinsp;3\u0026ndash;9) for bulbar/penobulbar strictures and 22 (IQR\u0026thinsp;=\u0026thinsp;19\u0026ndash;26) to 5 (IQR\u0026thinsp;=\u0026thinsp;3\u0026ndash;7) for bulbomembranous/membranous strictures.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of preoperative and postoperative functional outcomes of patients treated with Optilume\u0026reg; drug-coated balloon for the management of urethral strictures.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003ePeak urinary flow (Qmax) before surgery [ml/s], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePenile\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBulbar/ Penobulbar\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;59)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBulbomembranous/ Membranous\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;13)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBladder neck\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (\u003cspan additionalcitationids=\"CR6 CR7 CR8 CR9\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (\u003cspan additionalcitationids=\"CR5 CR6 CR7 CR8 CR9 CR10 CR11\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePost-void residual (PVR) before surgery [ml], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (0\u0026ndash;46)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78 (30\u0026ndash;196)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0\u0026ndash;45)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0\u0026ndash;0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eIPSS before surgery [0\u0026ndash;35], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.0 (11\u0026ndash;24)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22 (19\u0026ndash;26)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePeak urinary flow (Qmax) at 3 months [ml/s], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (12\u0026ndash;20)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19 (15\u0026ndash;25)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18.8 (17\u0026ndash;21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e18 (15\u0026ndash;21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePost-void residual (PVR) at 3 months [ml], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0\u0026ndash;12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (0\u0026ndash;50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0\u0026ndash;5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e50 (25\u0026ndash;75)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eIPSS at 3 months [0\u0026ndash;35], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan additionalcitationids=\"CR4 CR5 CR6 CR7 CR8\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (\u003cspan additionalcitationids=\"CR4 CR5 CR6\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStricture-free survival\u003c/h2\u003e \u003cp\u003eMedian follow-up duration ranged from 3 to 11 months depending on stricture location. Stricture free survival for different types of urethral stricture is displayed in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e4\u003c/span\u003e. Stricture persistence was observed in 20 (23%) patients, with no persistence among bladder neck strictures. Stricture persistence was most frequently observed in patients with bulbomembranous/membranous strictures (30.8%, n\u0026thinsp;=\u0026thinsp;4), followed by bulbar/penobulbar (25.4%, n\u0026thinsp;=\u0026thinsp;15) and penile strictures (9.1%, n\u0026thinsp;=\u0026thinsp;1). There was no significant difference between persisting stricture during follow-up for the different types of urethral stricture (p\u0026thinsp;=\u0026thinsp;0.5).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eStricture-free survival of patients undergoing Optilume\u0026reg; DCB for different types of urethral stricture.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eMonths of follow-up [months], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePenile\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBulbar/Penobulbar\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;59)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBulbomembranous/ Membranous\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;13)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBladder neck\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (\u003cspan additionalcitationids=\"CR2 CR3 CR4 CR5\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan additionalcitationids=\"CR4 CR5 CR6\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (\u003cspan additionalcitationids=\"CR7 CR8 CR9 CR10 CR11 CR12\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.07\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePersisting stricture during follow-up, n(%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1 (9.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e15 (25.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4 (30.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePostoperative complications\u003c/h2\u003e \u003cp\u003ePostoperative data is displayed in Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Postoperative complications within 30 days occurred in 5 (5.8%) patients. 3 patients (5.1%) with bulbar/penobulbar stricture and 2 patients (15.4%) with bulbomembranous/membranous stricture without a significant difference between them (p\u0026thinsp;=\u0026thinsp;0.4). There were no postoperative complications detected for patients treated with penile or bladder neck strictures.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePostoperative data of patients treated with Optilume\u0026reg; drug-coated balloon for the management of urethral strictures.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003ePostoperative complications within 30 days, n(%)\u003c/b\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePenile\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBulbar/ Penobulbar\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;59)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBulbomembranous/ Membranous\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;13)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBladder neck\u003c/p\u003e \u003cp\u003e(N\u0026thinsp;=\u0026thinsp;3)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (5.1)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (15.4)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.4\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLength of indwelling urethral catheter [days], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0\u0026ndash;0.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (0\u0026ndash;3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (0\u0026ndash;2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMonths of follow-up [months], median (IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (\u003cspan additionalcitationids=\"CR2 CR3 CR4 CR5\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan additionalcitationids=\"CR4 CR5 CR6\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9.5 (\u003cspan additionalcitationids=\"CR7 CR8 CR9 CR10 CR11 CR12\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10.5 (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePersisting stricture during follow-up, n(%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (9.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (25.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (30.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eFactors predictive of stricture recurrence\u003c/h2\u003e \u003cp\u003eFactors predicting stricture recurrence are displayed in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e. On multivariate logistic regression analysis, diabetes was the only independent predictor of symptomatic stricture recurrence (OR\u0026thinsp;=\u0026thinsp;7.66, 95% CI 1.55\u0026ndash;47.12, p\u0026thinsp;=\u0026thinsp;0.01).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eMultivariable logistic regression predicting stricture during follow up.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOdds Ratio (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAge\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1 (0.97\u0026ndash;1.04)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e7.66 (1.55\u0026ndash;47.12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSmoking\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.48 (0.12\u0026ndash;1.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eStricture site\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.35 (0.74\u0026ndash;115)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePrior radiation therapy\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.02 (0.08\u0026ndash;13.74)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn our multicentre, retrospective study we provide real-world data on effectiveness and functional outcomes of Optilume\u0026reg; DCB treatment of urethral stricture according to stricture location. Our results show favourable short- and mid-term results regarding stricture free rate and safety profile for all stricture locations. In our patient cohort, stricture-free rate during follow-up was the highest for bladder neck stricture, with no recurrence occurring, followed by penile strictures, bulbar/penobulbar and lastly bulbomembranous/membranous strictures.\u003c/p\u003e \u003cp\u003eThe follow-up time was variable between the groups ranging from 3 months to 13 months. Functional outcomes, assessed by IPSS and Qmax before and after surgery, demonstrated symptom reduction and improvement in peak urinary flow across all stricture type groups. The rate of postoperative complications within 30 days after surgery was low with a total of 5 patients (5.8%) experiencing complications. In line with the current literature our data supports the high safety profile of Optilume\u0026reg; treatment across different stricture types.\u003c/p\u003e \u003cp\u003eOur study adds valuable real-word data for not only anterior urethral strictures but also posterior stricture types such as bulbomembranous/membranous and bladder neck strictures. As the recommendation for Optilume\u0026reg; use nowadays mainly relies on the results of the ROBUST III study, presenting a 83% stricture free rate for short anterior urethral strictures after 1 year (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), it is important to further investigate the effectiveness of Optilume\u0026reg; for also posterior urethral stricture disease to extend the use of application. Although only 3 patients in total were included in our analysis with bladder neck stricture, reducing the generalizability due to low patient count, it is notable that none of these patients developed a stricture recurrence, suggesting that patient with bladder neck stricture might benefit from Optilume\u0026reg; DCB treatment. These findings are in line with the results of Tosev et al. who reported a no stricture recurrence for their 16 patients with bladder neck stenosis and vesicourethral anastomosis stenosis treated with Optilume\u0026reg; DCB after 12 months (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e).\u003c/p\u003e \u003cp\u003ePatients in our cohort with posterior urethral strictures were older than those with anterior strictures, with a median age of 74 years in the bulbomembranous/membranous group and 75 years in the bladder neck group. Given the greater comorbidity burden often associated with advanced age, minimally invasive approaches such as Optilume\u0026reg; may be particularly beneficial in this population. However, in a single-centre retrospective study, Karanjia et el. found no significant association between age and treatment failure after Optilume\u0026reg; treatment, suggesting that advanced age alone may not negatively impact treatment outcome (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Thus, elderly patients may benefit from this minimally invasive, which can also be performed under local anaesthesia.\u003c/p\u003e \u003cp\u003eTo optimize patient selection for different treatment modalities it is essential to look at comorbidities that could influence treatment effectiveness and functional outcome. On multivariant logistic regression analysis, diabetes was the only independent predictor of symptomatic stricture recurrence in our patient cohort. Diabetes mellitus is known to negatively influence wound healing due to impaired microvascular circulation, as well as promoting hypertrophic scar formation (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), which may plausibly contribute to recurrent urethral fibrosis and reduce treatment success following Optilume\u0026reg; treatment. Given the importance of appropriate patient selection and individualized patient consulting, it is important that further studies evaluate the influence of comorbidities on treatment success.\u003c/p\u003e \u003cp\u003eThis study has several limitations, which need to be acknowledged. The retrospective design of this study is a limitation itself leading to selection bias. Furthermore, the variability of the follow-up time between stricture type groups, ranging from 3 to 13 months, needs to be addressed because it limits comparability for stricture-free rates. In addition, the relatively short follow-up time in some stricture type groups only allows assessment of short-term outcomes so that conclusions regarding durability of treatment effects cannot be made. Moreover, the evaluation of stricture recurrence was defined as any symptomatic stricture in need of re-treatment, which may lead to underestimation of stricture recurrence due to the lack of cystoscopic confirmation.\u003c/p\u003e \u003cp\u003eDespite these limitations, our study adds important real-world data on the effectiveness and safety of Optilume\u0026reg; DCB dilatation for different stricture types as well as looking at factors influencing stricture recurrence.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eOptilume\u0026reg; DCB showed encouraging efficacy and safety across different urethral stricture sites, achieving high stricture-free rates and improved urinary flow. Diabetes was the only factor independently associated with recurrence, highlighting the value of optimizing patient selection and individualized consultation. In the future larger, prospective, long-term studies are needed to validate these findings and define ideal candidates for Optilume\u0026reg; treatment.\u003c/p\u003e "},{"header":"Declarations","content":" \u003ch2\u003eConflict of Interest\u003c/b\u003e:\u003c/h2\u003e \u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eStatement of human rights\u003c/strong\u003e \u003cp\u003eAll persons gave their informed consent to use their data (deidentified).\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eCompliance with Ethical Standards:\u003c/strong\u003e \u003cp\u003eEthical committee approval was given (BASEC 2025\u0026thinsp;\u0026minus;\u0026thinsp;01438).\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eNo funding was received for this study.\u003c/p\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eAuthors Contribution\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eSeiler\u003c/strong\u003e \u003cp\u003eManuscript writing and editing, Data management\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eDe Giorgi\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eMantica\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eKarapanos\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eViktorin\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAhmed\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eClements\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eG\u0026uuml;demann\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eJonusaite\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eGerritsen\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eSubotic\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eKwiatkowski\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eSauer\u003c/strong\u003e \u003cp\u003eOther (reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eWyler\u003c/strong\u003e \u003cp\u003eOther (supervision, reviewing and editing)\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAfferi\u003c/strong\u003e \u003cp\u003eProtocol/project development, Manuscript editing, Data analysis, Data collection and management, Other (supervision)\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data supporting the findings of this study are not publicly available due to patient privacy and institutional restrictions. De-identified data may be made available from the corresponding author upon reasonable request and with permission of the participating institutions.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHampson LA, McAninch JW, Breyer BN (2014) Male urethral strictures and their management. Nat Rev Urol 11(1):43\u0026ndash;50\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYuruk E, Yentur S, Cakir OO, Ertas K, Serefoglu EC, Semercioz A (2016) Catheter dwell time and diameter affect the recurrence rates after internal urethrotomy. Turk J Urol 42(3):184\u0026ndash;189\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAl Taweel W, Seyam R (2015) Visual Internal Urethrotomy for Adult Male Urethral Stricture Has Poor Long-Term Results. Adv Urol 2015:656459\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKluth LA, Ernst L, Vetterlein MW, Meyer CP, Reiss CP, Fisch M et al (2017) Direct Vision Internal Urethrotomy for Short Anterior Urethral Strictures and Beyond: Success Rates, Predictors of Treatment Failure, and Recurrence Management. Urology 106:210\u0026ndash;215\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMeeks JJ, Erickson BA, Granieri MA, Gonzalez CM (2009) Stricture recurrence after urethroplasty: a systematic review. J Urol 182(4):1266\u0026ndash;1270\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShen J, Vale L, Goulao B, Whybrow P, Payne S, Watkin N et al (2021) Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis. BMC Urol 21(1):76\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGauhar V, Yuen SKK, Gadzhiev N, Wroclawski M, Pirola GM, Lim EJ et al (2025) Optilume, a minimally invasive solution for BPH and urethral stricture: what we know, what we need? an EAU endourology scoping review. BMC Urol 25(1):196\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlhamdani Z, Ong S, Zhong W, Chin P (2024) Optilume((R)) Drug-Coated Balloon May Lower the Re-Treatment Rate Postintervention for Challenging Urethral Stricture Disease in Long-Term Follow-Up: A Prospective Cohort Study. J Endourol 38(11):1192\u0026ndash;1200\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWill TA, Polcari AJ, Garcia JG, Ouwenga MK, Voelzke BB, Greisler HP et al (2011) Paclitaxel Inhibits Ureteral Smooth Muscle Cell Proliferation and Collagen Production in the Absence of Cell Toxicity. J Urol 185(1):335\u0026ndash;340\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSrikanth P, DeLong J, Virasoro R, Elliott SP (2025) A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST III Study. J Endourol 39(9):968\u0026ndash;974\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eElliott SP, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Carrier S et al (2022) One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume((R)) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol 207(4):866\u0026ndash;875\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTosev G, Damgov I, Kuehhas F, Borgmann H, Struck J, Salem J et al (2025) Off-label Use of the Optilume Drug-coated Balloon in the Treatment of Bladder Neck Stenosis and Vesicourethral Anastomosis Stenosis. Eur Urol Open Sci 75:101\u0026ndash;105\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaranjia R, Pineda-Turner A, Watts I, Whiting D, Chetwood A (2025) Optilume(R) Balloon Dilatation for Urethral Stricture Disease: An Institutional Review of Outcomes for Multiple Stricture Aetiologies and Characteristics. Cureus 17(9):e91919\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZheng W, Lai W, Zhang Y, Wang X, Yang K, Zhou X et al (2025) Type 2 diabetes as a risk factor for promoting hypertrophic scar formation after wound healing: a two-sample mendelian randomization study. Arch Dermatol Res 317(1):656\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":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Balloon-dilatation, Optilume, Urethral stricture, Outcomes","lastPublishedDoi":"10.21203/rs.3.rs-9398079/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9398079/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction \u0026amp; Objectives:\u003c/h2\u003e \u003cp\u003eThe Optilume\u0026reg; drug-coated balloon (DCB), combining mechanical dilation with localized paclitaxel delivery, is a novel minimally invasive treatment for urethral stricture disease. However, data on its effectiveness across different stricture locations are limited. This study evaluates functional outcomes following treatment for different strictures locations.\u003c/p\u003e\u003ch2\u003eMaterials \u0026amp; Methods:\u003c/h2\u003e \u003cp\u003e This retrospective multicenter study included patients treated with Optilume\u0026reg; DCB for urethral strictures at five European tertiary care referral centers (June 2023 - June 2025). Stricture length was assessed by retrograde urethrography, cystoscopy, or both. Recurrence was defined as any symptomatic stricture requiring treatment. A multivariable logistic regression using preoperative data was developed to predict recurrence requiring treatment.\u003c/p\u003e\u003ch2\u003eResults:\u003c/h2\u003e \u003cp\u003eIn total 86 patients were included across four stricture locations: penile (n\u0026thinsp;=\u0026thinsp;11, 13%), bulbar/penobulbar (n\u0026thinsp;=\u0026thinsp;59, 68%), bulbomembranous/membranous (n\u0026thinsp;=\u0026thinsp;13, 15%) and bladder neck (n\u0026thinsp;=\u0026thinsp;3, 4%). Postoperative complications within 30 days occurred in 5 (5.8%) patients. Median follow-up duration ranged from 3 to 11 months. Median peak urinary flow increased from 3.5\u0026ndash;8.8 mL/s preoperatively to 13.5\u0026ndash;19 mL/s at 3 months. Stricture-free rates were highest in penile (91%) and bladder neck (100%) strictures, and lower for bulbar (74%) and bulbomembranous/membranous (69%) strictures. On multivariate logistic regression analysis, diabetes was an independent predictor of stricture recurrence (OR\u0026thinsp;=\u0026thinsp;7.66, 95% CI 1.55\u0026ndash;47.12, p\u0026thinsp;=\u0026thinsp;0.01).\u003c/p\u003e\u003ch2\u003eConclusions:\u003c/h2\u003e \u003cp\u003eOptilume\u0026reg; DCB showed encouraging efficacy and safety across different urethral stricture locations, achieving high stricture-free rates and improved urinary flow. Diabetes independently predicted recurrence, highlighting the value of optimizing modifiable risk factors.\u003c/p\u003e","manuscriptTitle":"Outcomes of patients undergoing Optilume® drug-coated balloon for different locations of urethral strictures: results from a multicenter cohort","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-30 11:57:16","doi":"10.21203/rs.3.rs-9398079/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-05-01T12:30:18+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-30T23:08:18+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"285204103065288909349311138963458659180","date":"2026-04-24T12:38:00+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-22T18:09:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"309228758329937784614218577404413120406","date":"2026-04-21T18:13:02+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-21T17:40:43+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-21T06:01:02+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-21T06:00:24+00:00","index":"","fulltext":""},{"type":"submitted","content":"World Journal of Urology","date":"2026-04-13T03:05:28+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"3cfd0e60-08f8-475c-b979-ced0d1277801","owner":[],"postedDate":"April 30th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Revision requested","date":"2026-05-01T12:30:18+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-30T23:08:18+00:00","index":13,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"in-revision","subjectAreas":[],"tags":[],"updatedAt":"2026-05-01T12:39:23+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-30 11:57:16","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9398079","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9398079","identity":"rs-9398079","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}