Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population

N/ANot Yet RecruitingNCT06827210

Aalborg University Hospital140 enrolled

Overview

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.

This randomized controlled trial aims to evaluate the safety and efficacy of the Optilume® drug-coated balloon (DCB) in the treatment of bulbar urethral strictures. The trial includes adult male participants who have not received prior treatment for urethral strictures. Participants will be randomly assigned to one of two treatment groups: Optilume DCB or standard direct visual internal urethrotomy (DVIU). The primary objective of the study is to compare the recurrence rate of urethral strictures at 12 months between the two groups. Secondary objectives include assessing patient-reported outcomes (using USS-PROM, IPSS, and IIEF-5), urethral patency (via Qmax and post-void residual volume), and safety (monitoring adverse events). Follow-Up Schedule: At Diagnosis: Baseline assessments will include cystoscopy, uroflowmetry (Qmax), post-void residual (PVR), patient-reported outcomes (USS-PROM, IPSS, and IIEF-5), and demographic data (age, sex, BMI, comorbidities, and smoking status). Informed consent will also be obtained. Day 3 (Foley Removal): Participants will return for catheter removal. 6-Month Follow-Up: Assessments will include Qmax, PVR, and patient-reported outcomes (USS-PROM, IPSS, and IIEF-5). 12-Month Follow-Up: Final assessments will include cystoscopy, Qmax, PVR, and patient-reported outcomes (USS-PROM, IPSS, and IIEF-5). The study will recruit 140 participants across multiple sites, with recruitment anticipated to span approximately 17.5 months. Data will be analyzed using Kaplan-Meier survival curves to compare recurrence rates, and log-rank tests will be used to assess statistical significance. Modified Poisson regression will be applied to evaluate potential confounders. This study aims to provide robust evidence on the effectiveness of Optilume DCB in reducing stricture recurrence, improving patient outcomes, and offering a safe alternative to standard treatment.

Study Type

Interventions

Optilume DCBDEVICE

Optilume 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

Standard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. * Able to provide written informed consent. Exclusion Criteria: * Female (chromosomal) sex. * History of prior urethral stricture or prior treatment thereof. * History of hypospadias repair. * History of genital lichen sclerosis. * 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. * Known allergy or hypersensitivity to paclitaxel or any component of the Optilume DCB. * Known peripheral artery disease. * Severe comorbidities with an American Society of Anesthesiologists (ASA) score of 4 or higher. * Patients unable to comply with follow-up protocols or provide informed consent.

Outcomes

Primary Outcomes

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."

Time frame: 12 months post-intervention

Secondary Outcomes

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.