[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urethral-stricture-less-than-2-cm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urethral-stricture-less-than-2-cm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100579662","treatment-of-bulbar-urethral-strictures-with-optilume-drug-coated-balloons-in-an-untreated-population-100579662",false,"NCT06827210","Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population","FIRST-CARE","Inclusion Criteria:\n\n* Male patients aged 18 years or older.\n* Diagnosed with a treatment-naive, single bulbar urethral stricture.\n* Stricture length ≤3 cm.\n* Eligible for local treatment with paclitaxel.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Female (chromosomal) sex.\n* History of prior urethral stricture or prior treatment thereof.\n* History of hypospadias repair.\n* History of genital lichen sclerosis.\n* Active or unresolved confounding etiology, including bladder neck contracture, neurogenic bladder, known or being evaluated for symptomatic benign prostatic hyperplasia (BPH) or surgical treatment for BPH within the last 5 years.\n* Known allergy or hypersensitivity to paclitaxel or any component of the Optilume DCB.\n* Known peripheral artery disease.\n* Severe comorbidities with an American Society of Anesthesiologists (ASA) score of 4 or higher.\n* Patients unable to comply with follow-up protocols or provide informed consent.","MALE","18 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"NA","This randomized controlled trial investigates the effectiveness and safety of the Optilume® drug-coated balloon (DCB) compared to standard direct visual internal urethrotomy (DVIU) in the treatment of bulbar urethral strictures. The primary objective is to assess freedom from repeat intervention at 12 months. Secondary objectives include evaluating urethral patency, urinary symptoms, and sexual function through objective measures (Qmax, PVR, cystoscopy) and patient-reported outcomes (USS-PROM, IPSS, IIEF-5). The study will recruit 140 participants across multiple sites, with follow-ups conducted at 6 and 12 months. This trial seeks to provide evidence for Optilume DCB as a safe and effective alternative to standard treatment.",[26,27,28,29],"Urethral Stricture","Urethral Stricture, Anterior","Urethral Stricture, Male","Urethral Stricture Less Than 2 cm",[26,31,32,33,34],"Optilume Drug-Coated Balloon","DVIU","Urology","Patient-Reported Outcomes","NOT_YET_RECRUITING","2025-02-13",{"date":38,"type":39},"2025-02-14","ACTUAL",{"date":41,"type":20},"2025-02-07",{"date":43,"type":20},"2027-07",{"name":45,"class":46},"Aalborg University Hospital","OTHER",3]