Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population (FIRST-CARE)

Aalborg University Hospital

Status: Not yet enrolling

Conditions: Urethral Stricture, Anterior; Urethral Stricture; Urethral Stricture, Male; Urethral Stricture Less Than 2 cm

Treatments: Device: Optilume DCB; Procedure: Standard Direct Visual Internal Urethrotomy (DVIU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06827210

F2024-214

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Optilume Drug-Coated Balloon (DCB)

Experimental group

Description:

Participants in this arm will receive treatment with the Optilume drug-coated balloon (DCB), which combines mechanical dilation with localized drug delivery of paclitaxel to reduce stricture recurrence and promote healing.

Treatment:

Device: Optilume DCB

Standard Direct Visual Internal Urethrotomy (DVIU)

Active Comparator group

Description:

Participants in this arm will undergo standard Direct Visual Internal Urethrotomy (DVIU), a commonly performed endoscopic procedure for the treatment of bulbar urethral strictures.

Treatment:

Procedure: Standard Direct Visual Internal Urethrotomy (DVIU)