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Introduction and Hypothesis <p>To evaluate the feasibility, safety, and preliminary clinical outcomes of paclitaxel-coated balloon (Optilume®) dilation in women with urethral stricture disease, a condition with limited minimally invasive treatment options.</p> Methods <p>Multicenter, retrospective case series, including nine consecutive female patients treated with Optilume® between May 2023 and November 2025. Clinical characteristics, uroflowmetry, post-void residual (PVR), and patient-reported outcomes were collected. A uroflowmetric response was defined as a ≥ 50% increase in maximum flow rate (Qmax). Symptomatic improvement was assessed using the Patient Global Impression of Improvement (PGI-I) scale. Pre- and postoperative Qmax and PVR were compared using the Wilcoxon signed-rank test.</p> Results <p>Nine women were included (mean age 63.2&#xa0;years; SD 15.6). Median Qmax improved from 8.6 to 13.6&#xa0;mL/s (<i>p</i> = 0.012). Median PVR decreased from 56 to 0&#xa0;mL (<i>p</i> = 0.043). A uroflowmetric response was achieved in 66.7% (6/9). All procedures were outpatient, with no intra- or postoperative complications and no de novo stress urinary incontinence. One patient (11.1%) required reintervention for recurrence at 5&#xa0;months, successfully managed with internal urethrotomy. All patients reported improvement on PGI-I: 66.7% (6/9) “very much better” and 33.3% (3/9) “better.” At short-term follow-up (mean 11&#xa0;months; variable), 88.9% (8/9) remained free of reintervention.</p> Conclusions <p>In this small, retrospective multicenter cohort, paclitaxel-coated balloon dilation appeared feasible and was not associated with major procedure-related complications in the short term, with encouraging functional and patient-reported improvements. These findings are preliminary and hypothesis-generating; prospective controlled studies with larger samples and longer, standardized follow-up are needed to better define effectiveness and durability.</p>

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Multicentric Preliminary Experience and Clinical Outcomes of Female Urethral Dilation Using a Paclitaxel-Coated Balloon

  • 期刊论文

  • 发表日期：

    2026年5月20日

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  • David Carracedo,
  • Ghali Belkahia,
  • María D. Sánchez-Gallego,
  • Renán Otta,
  • Esther García Rojo,
  • Tamara Jerez,
  • Guillermo Celada,
  • Clara Sánchez-Guerrero,
  • Lucía Estebán,
  • César Minguez,
  • José Manuel De la Morena,
  • Javier Romero-Otero

摘要

Introduction and Hypothesis

To evaluate the feasibility, safety, and preliminary clinical outcomes of paclitaxel-coated balloon (Optilume®) dilation in women with urethral stricture disease, a condition with limited minimally invasive treatment options.

Methods

Multicenter, retrospective case series, including nine consecutive female patients treated with Optilume® between May 2023 and November 2025. Clinical characteristics, uroflowmetry, post-void residual (PVR), and patient-reported outcomes were collected. A uroflowmetric response was defined as a ≥ 50% increase in maximum flow rate (Qmax). Symptomatic improvement was assessed using the Patient Global Impression of Improvement (PGI-I) scale. Pre- and postoperative Qmax and PVR were compared using the Wilcoxon signed-rank test.

Results

Nine women were included (mean age 63.2 years; SD 15.6). Median Qmax improved from 8.6 to 13.6 mL/s (p = 0.012). Median PVR decreased from 56 to 0 mL (p = 0.043). A uroflowmetric response was achieved in 66.7% (6/9). All procedures were outpatient, with no intra- or postoperative complications and no de novo stress urinary incontinence. One patient (11.1%) required reintervention for recurrence at 5 months, successfully managed with internal urethrotomy. All patients reported improvement on PGI-I: 66.7% (6/9) “very much better” and 33.3% (3/9) “better.” At short-term follow-up (mean 11 months; variable), 88.9% (8/9) remained free of reintervention.

Conclusions

In this small, retrospective multicenter cohort, paclitaxel-coated balloon dilation appeared feasible and was not associated with major procedure-related complications in the short term, with encouraging functional and patient-reported improvements. These findings are preliminary and hypothesis-generating; prospective controlled studies with larger samples and longer, standardized follow-up are needed to better define effectiveness and durability.