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.
Male patients aged 18 years or older.
Diagnosed with a treatment-naive, single bulbar urethral stricture.
Stricture length ≤3 cm.
Eligible for local treatment with paclitaxel.
Female (chromosomal) sex.
History of prior urethral stricture or prior treatment thereof.
History of hypospadias repair.
History of genital lichen sclerosis.
Parallel
Optilume DCB
DeviceOptilume DCB is a drug-coated balloon catheter designed for the treatment of bulbar urethral strictures. It combines mechanical dilation with localized drug delivery to reduce stricture recurrence and promote urethral healing. The balloon is coated with paclitaxel, an antiproliferative agent, to minimize scar tissue formation and improve treatment outcomes.
Standard Direct Visual Internal Urethrotomy (DVIU)
Procedure/SurgeryStandard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures.
Freedom from Repeat Intervention at 12 Months
"The primary outcome is the proportion of participants who remain free from repeat intervention for urethral stricture recurrence at 12 months following treatment. Repeat intervention is defined as any procedure to address stricture recurrence, such as dilation, DVIU, or urethroplasty. Referrals for repeat interventions made within the 12-month follow-up period will also be included, even if the procedure itself is scheduled beyond the 12-month mark."
Urethral Patency Assessed via Cystoscopy at 12 Months
Urethral patency will be assessed using cystoscopy at 12 months. Patency is defined as the absence of visually confirmed narrowing that compromises the urethral lumen.
Maximum Urinary Flow Rate (Qmax) at 12 Months
The maximum urinary flow rate (Qmax) will be measured using uroflowmetry at 12 months as an indicator of urethral function. An improvement in Qmax is considered indicative of treatment success.
Post-Void Residual (PVR) Volume at 12 Months
Post-void residual (PVR) volume will be assessed using ultrasound at 12 months to evaluate bladder emptying efficiency. Lower PVR values are associated with successful treatment outcomes.
Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM)
The Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM) is a patient-reported outcome measure consisting of: (1) Lower Urinary Tract Symptoms Construct (Q1-6) from International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (0-24, higher = worse symptoms); (2) LUTS-Specific QoL (Q7) (1-4, higher = worse QoL); (3) Peeling's Voiding Picture (Q8) (1-4, 1 = worst, 4 = best voiding); and (4) EQ-5D with an index value (1.000 to 0.033, higher = better health) and EQ-Visual Analogue Scale (0-100, higher = better health status), based on the Danish EQ-5D-5L Value Set (PMID 33527304).
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Aalborg University Hospital
Lead sponsor
Gødstrup Hospital
Collaborator
Regionshospital Nordjylland
Collaborator
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