Purpose <p>Drug-coated balloon (DCB) urethral dilatation which offers an alternative to standard endoscopic treatments of male anterior urethral stricture disease (AUSD). Its ease of delivery has facilitated its use by urologists with various subspecialty interests. The objective of this study was to characterise real-world practice patterns of a DCB device.</p> Methods <p>An exploratory cross-sectional online survey was distributed to Optilume<sup>®</sup> users via national and international urological societies and device distributor mailing lists. Descriptive and inferential statistics were performed using SPSS software.</p> Results <p><i>N</i> = 102 urologists responded to the survey of whom <i>n</i> = 47 (46%) were reconstructive subspecialists. DCB dilatation was predominantly performed under general anaesthesia (<i>n</i> = 59, 58%). Significant variation was seen with catheter duration, perioperative antibiotic use and post-procedure contraception advice. Off-label use was common with respondents offering DCB for penile urethral strictures (65%), primary treatment (64%) and bladder neck stenoses (65%). Higher-volume users (≥ 10/year) were more likely to perform DCB under flexible cystoscopy (OR 5.14, 95% 1.57–16.79, <i>p</i> = 0.007), bladder neck stricture (OR 4.66, 95% CI 1.55–14.03, <i>p</i> = 0.006), and for recurrences (OR 6.92, 95% CI 2.22–21.6, <i>p</i> = 0.001). Limited practitioner experience, an evidence gap, and the importance of shared decision making were highlighted on thematic analysis.</p> Conclusions <p>This study provides an insight into the early experience a novel DCB among practicing urologists. Further research is required to optimize patient selection, procedural protocols and the understanding of long-term outcomes.</p>

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Practices in urethral stricture management with drug-coated balloon dilatation: an international survey

  • Diarmuid D. Sugrue,
  • John O’Connor,
  • Łukasz Białek,
  • Francesco Chierigo,
  • Mikołaj Frankiewicz,
  • François Xavier Madec,
  • Behzad Abbasi,
  • Leonidas Karapanos,
  • Jakob Klemm,
  • Mattia Lo Re,
  • Juan Diego Tinajero,
  • Jordán Scherñuk,
  • Guglielmo Mantica,
  • Paul Neuville,
  • Maciej Oszczudłowski,
  • Wesley Verla,
  • Malte W. Vetterlein,
  • Niall F Davis,
  • Felix Campos-Juanatey,
  • Elaine J. Redmond

摘要

Purpose

Drug-coated balloon (DCB) urethral dilatation which offers an alternative to standard endoscopic treatments of male anterior urethral stricture disease (AUSD). Its ease of delivery has facilitated its use by urologists with various subspecialty interests. The objective of this study was to characterise real-world practice patterns of a DCB device.

Methods

An exploratory cross-sectional online survey was distributed to Optilume® users via national and international urological societies and device distributor mailing lists. Descriptive and inferential statistics were performed using SPSS software.

Results

N = 102 urologists responded to the survey of whom n = 47 (46%) were reconstructive subspecialists. DCB dilatation was predominantly performed under general anaesthesia (n = 59, 58%). Significant variation was seen with catheter duration, perioperative antibiotic use and post-procedure contraception advice. Off-label use was common with respondents offering DCB for penile urethral strictures (65%), primary treatment (64%) and bladder neck stenoses (65%). Higher-volume users (≥ 10/year) were more likely to perform DCB under flexible cystoscopy (OR 5.14, 95% 1.57–16.79, p = 0.007), bladder neck stricture (OR 4.66, 95% CI 1.55–14.03, p = 0.006), and for recurrences (OR 6.92, 95% CI 2.22–21.6, p = 0.001). Limited practitioner experience, an evidence gap, and the importance of shared decision making were highlighted on thematic analysis.

Conclusions

This study provides an insight into the early experience a novel DCB among practicing urologists. Further research is required to optimize patient selection, procedural protocols and the understanding of long-term outcomes.