Scholarlink

Background <p>Urethral stricture disease remains a challenging condition in urology, particularly in cases with recurrent anterior urethral narrowing following prior endoscopic treatments. Traditional options such as dilation and direct vision internal urethrotomy (DVIU) are limited by high failure rates. The Optilume<sup>®</sup> drug-coated balloon (DCB) delivers mechanical dilation combined with localized paclitaxel delivery, aiming to reduce restenosis and improve durability.</p> Objective <p>To evaluate the short-term functional outcomes and safety of Optilume<sup>®</sup> DCB in patients with recurrent urethral strictures.</p> Design, setting, and participants <p>This was a prospective single-center study including 35 male patients with anterior urethral strictures ≤ 3&#xa0;cm and at least one prior endoscopic treatment. Outcomes were assessed at 1, 3, and 6&#xa0;months post-procedure.</p> Outcome measurements and statistical analysis <p>Primary outcomes included changes in Qmax (uroflowmetry), post-void residual (PVR), IPSS, and erectile function (IIEF-5). Recurrence was defined as symptomatic deterioration, Qmax &lt; 10&#xa0;mL/s, or need for retreatment. Paired t-tests were used for pre- and post-treatment comparisons, with p &lt; 0.05 considered statistically significant. As this was an exploratory pilot study, no formal sample size calculation was performed; analyses were descriptive and hypothesis-generating.</p> Results and limitations <p>Mean Qmax improved from 10.2 ± 4.9 to 21.6 ± 3.1&#xa0;mL/s (p &lt; 0.001), and PVR decreased from 74.6 ± 36.3 to 24.8 ± 16.0&#xa0;mL (p &lt; 0.001). IPSS improved from 21.8 ± 4.8 to 8.7 ± 2.0 (p &lt; 0.0001), and IIEF-5 scores increased from 13.7 ± 7.7 to 18.5 ± 7.6 (p = 0.012). The recurrence rate at 6&#xa0;months was 8.6% (3/35). Minor adverse events included transient hematuria and dysuria. No Clavien-Dindo grade ≥ 2 complications were recorded. Study limitations include its single-arm, non-randomized design and relatively short follow-up, limiting direct comparison with DVIU, urethroplasty, or emerging minimally invasive surgical therapies (MISTs).</p> Conclusions <p>Optilume<sup>®</sup> DCB treatment demonstrated significant improvements in urinary flow and symptoms with a low recurrence and complication rate at 6&#xa0;months. It may serve as a minimally invasive alternative for patients unsuitable or unwilling to undergo urethroplasty. Further prospective evaluation is warranted, including its potential role in bladder neck sclerosis and benign prostatic obstruction.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Single-center prospective experience with Optilume® drug-coated balloon for recurrent urethral strictures: preliminary functional and safety outcomes

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月29日

查看全文
  • Antonio Cretì,
  • Mauro Ragonese,
  • Pierluigi Russo,
  • Nazario Foschi,
  • Giovanni Battista Filomena,
  • Antonio Silvestri,
  • Fabrizio Fantasia,
  • Vincenzo Cavarra,
  • Eros Scarciglia,
  • Francesco Pio Bizzarri,
  • Mariachiara Sighinolfi,
  • Bernardo Maria Cesare Rocco,
  • Francesco Pinto

摘要

Background

Urethral stricture disease remains a challenging condition in urology, particularly in cases with recurrent anterior urethral narrowing following prior endoscopic treatments. Traditional options such as dilation and direct vision internal urethrotomy (DVIU) are limited by high failure rates. The Optilume® drug-coated balloon (DCB) delivers mechanical dilation combined with localized paclitaxel delivery, aiming to reduce restenosis and improve durability.

Objective

To evaluate the short-term functional outcomes and safety of Optilume® DCB in patients with recurrent urethral strictures.

Design, setting, and participants

This was a prospective single-center study including 35 male patients with anterior urethral strictures ≤ 3 cm and at least one prior endoscopic treatment. Outcomes were assessed at 1, 3, and 6 months post-procedure.

Outcome measurements and statistical analysis

Primary outcomes included changes in Qmax (uroflowmetry), post-void residual (PVR), IPSS, and erectile function (IIEF-5). Recurrence was defined as symptomatic deterioration, Qmax < 10 mL/s, or need for retreatment. Paired t-tests were used for pre- and post-treatment comparisons, with p < 0.05 considered statistically significant. As this was an exploratory pilot study, no formal sample size calculation was performed; analyses were descriptive and hypothesis-generating.

Results and limitations

Mean Qmax improved from 10.2 ± 4.9 to 21.6 ± 3.1 mL/s (p < 0.001), and PVR decreased from 74.6 ± 36.3 to 24.8 ± 16.0 mL (p < 0.001). IPSS improved from 21.8 ± 4.8 to 8.7 ± 2.0 (p < 0.0001), and IIEF-5 scores increased from 13.7 ± 7.7 to 18.5 ± 7.6 (p = 0.012). The recurrence rate at 6 months was 8.6% (3/35). Minor adverse events included transient hematuria and dysuria. No Clavien-Dindo grade ≥ 2 complications were recorded. Study limitations include its single-arm, non-randomized design and relatively short follow-up, limiting direct comparison with DVIU, urethroplasty, or emerging minimally invasive surgical therapies (MISTs).

Conclusions

Optilume® DCB treatment demonstrated significant improvements in urinary flow and symptoms with a low recurrence and complication rate at 6 months. It may serve as a minimally invasive alternative for patients unsuitable or unwilling to undergo urethroplasty. Further prospective evaluation is warranted, including its potential role in bladder neck sclerosis and benign prostatic obstruction.