Global Survey on Drug-Coated Balloon Use for Male Urethral Stricture Treatment

Overview

This international survey of 102 urologists across 14 countries characterizes real-world utilization patterns of drug-coated balloon (DCB) dilatation for male anterior urethral stricture disease (AUSD). Findings reveal diverse procedural techniques, perioperative management, and postoperative counseling practices, highlighting the growing adoption of DCB as a minimally invasive alternative to traditional treatments.

Background

Male anterior urethral stricture disease is a fibrotic condition causing urinary obstruction with high recurrence rates after conventional endoscopic treatments such as direct vision internal urethrotomy (DVIU) and coaxial dilatation. Urethroplasty offers better durability but requires specialized expertise and carries higher morbidity. Drug-coated balloon dilatation, specifically with the FDA-approved Optilume® device coated with paclitaxel, inhibits fibroblast proliferation to reduce scar formation and extend stricture-free intervals. Clinical trials like ROBUST III have demonstrated superior patency and reduced reintervention rates with DCB compared to standard care, supporting its role as a minimally invasive treatment option.

Data Highlights

The survey collected responses from 102 urologists practicing in 14 countries, encompassing diverse geographic regions and practice settings. Data included practitioner demographics, experience with urethroplasty and reconstructive urology, DCB-specific experience, indications for device use, procedural techniques, perioperative management, and postoperative care protocols. Statistical analyses were performed to explore associations between respondent characteristics and DCB use.

Key Findings

• DCB dilatation is increasingly utilized worldwide as a minimally invasive alternative for male AUSD, particularly in patients with short strictures and prior failed endoscopic treatments.
• Practitioners employ varied procedural techniques and perioperative management strategies, reflecting a lack of standardized protocols.
• Postoperative counseling practices differ, with some clinicians emphasizing symptom monitoring and others focusing on objective measures such as uroflowmetry.
• Most respondents reported favorable clinical outcomes consistent with published trial data, including sustained symptom relief and low rates of serious adverse events.
• The survey identified knowledge gaps and practice variability that may inform future guideline development and clinical research priorities.

Clinical Implications

The findings support the integration of DCB dilatation into clinical practice as a viable, less invasive option for managing male anterior urethral strictures, especially in patients with recurrent disease after standard endoscopic treatments. Clinicians should consider individual patient factors and local expertise when selecting treatment modalities. Standardization of procedural and postoperative protocols may optimize outcomes and facilitate broader adoption.

Conclusion

This global survey provides valuable insights into contemporary DCB utilization patterns for male urethral stricture disease, underscoring its role as an effective minimally invasive treatment. Continued research and consensus-building are needed to harmonize practice and maximize patient benefit.

References

1. FDA Approval and Clinical Trials (2021-2024) -- Optilume® Drug-Coated Balloon in Urethral Stricture Disease
2. ROBUST III Trial (2024) -- Randomized Controlled Trial of DCB vs Standard Care
3. European Association of Urology Young Academic Urologists -- Survey on DCB Utilization