What is the role of Optilume (Drug-Eluting Balloon) in the treatment of urethral strictures using direct vision internal urethrotomy (DVIU)?

From the Guidelines

Optilume, a drug-eluting balloon, should be considered for the treatment of recurrent bulbar urethral strictures less than 3 cm in length, particularly when used in conjunction with direct vision internal urethrotomy (DVIU), as it has shown promising results in reducing stricture recurrence rates. The use of Optilume in this context is supported by the 2023 urethral stricture disease guideline amendment, which suggests that surgeons may perform urethral dilation or DVIU combined with drug-coated balloons for recurrent bulbar urethral strictures <3cm in length 1. This approach is particularly beneficial for patients who have failed previous endoscopic treatments, as repeated endoscopic management is unlikely to be successful, with failure rates of >80% 1.

Key Considerations

• The Optilume procedure involves mechanically dilating the strictured area while delivering paclitaxel, an anti-proliferative agent, directly to the urethral tissue.
• The treatment is performed under direct visualization, with the balloon positioned at the stricture site, inflated to dilate the narrowed area, and maintained for approximately 5 minutes to ensure adequate drug delivery to the tissue.
• Clinical studies have shown promising results with significantly lower recurrence rates compared to conventional DVIU alone, with success rates of approximately 70-80% at two years follow-up.
• Patients typically require catheterization for 7-14 days post-procedure, and the treatment can be performed as an outpatient procedure under various anesthesia options.

Benefits and Risks

• The anti-proliferative mechanism of paclitaxel disrupts cell division in the urethral tissue, thereby reducing the formation of the myofibroblasts responsible for stricture recurrence.
• The use of Optilume may reduce the need for repeated endoscopic procedures, which can cause longer strictures and increase the complexity of subsequent urethroplasty 1.
• However, the evidence to support the use of drug-coated balloons for first-time treatment of anterior urethral stricture is limited, and further studies are needed to fully evaluate its effectiveness 1.

From the Research

Optilume DVIU Treatment

• The Optilume drug-eluting balloon is used as an adjunct treatment for urethral strictures in men, aiming to prevent recurrence via the localized application of Paclitaxel 2.
• The treatment involves balloon dilatation followed by the application of the drug-coated balloon, which has been shown to be safe and effective in reducing the rates of recurrence for high-risk stricture disease 2.

Role of Optilume in DVIU

• The Optilume drug-coated balloon is applied after shallow direct vision internal urethrotomy with a cold knife, and has been found to improve voiding parameters and reduce the need for repeat procedures 2.
• Studies have shown that the use of Optilume in DVIU can delay or prevent the need for urethroplasty in patients with recurrent stricture disease 2.

Efficacy of DVIU

• Direct vision internal urethrotomy (DVIU) has been found to have varying success rates, with some studies reporting excellent outcomes and others showing poor long-term results 3, 4.
• The efficacy of DVIU is influenced by factors such as stricture length, degree of fibrosis, and previous endoscopic procedures 3, 4, 5.
• DVIU is generally considered a safe and simple technique, but may not be effective for strictures longer than 2 cm or recurrent cases 5.

Comparison of Treatment Options

• Optilume DVIU has been compared to other treatment options, including open urethral reconstruction and self-catheterization, and has been found to be a viable alternative for patients with recurrent stricture disease 2, 5.
• The choice of treatment depends on various factors, including the length and location of the stricture, as well as the patient's overall health and medical history 5.