Salem Johannes, Menendez-Suarez Juan Jose, Tosev Georgi, Borgmann Hendrik, Kuru Timur
Department of Urology, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontan, 14770 Brandenburg, Germany.
CUROS Urology Center, 50996 Cologne, Germany.
J Clin Med. 2025 Aug 26;14(17):6022. doi: 10.3390/jcm14176022.
Penile urethral stricture is a therapeutically challenging condition that significantly impacts quality of life and is often managed initially with urethral dilation or internal urethrotomy. However, both techniques are associated with high recurrence rates, limited long-term efficacy, and potential adverse effects, particularly in the penile urethra. Urethroplasty remains the gold standard but is invasive and not suitable for all patients. Optilume, a paclitaxel-coated balloon, combines mechanical dilation with localized drug delivery to reduce recurrence rates and the need for re-intervention. This study evaluated its effectiveness in patients with penile urethral strictures. A retrospective, multicenter study was conducted at two German clinics. Eight male patients (mean age 59) with symptomatic penile urethral strictures underwent Optilume treatment. Symptom severity was assessed using the International Prostate Symptom Score (IPSS) and quality of life (QoL) scores before and after treatment. The primary endpoint was symptom improvement, while the secondary endpoint was the need for reintervention. Patients were followed for a median of 16.5 months. Statistical analyses included Wilcoxon signed-rank and Mann-Whitney U tests. The median IPSS improved from 25.5 to 5.0 and QoL scores from 4.5 to 1.0 after treatment ( < 0.01 for both). No patients required reintervention during follow-up. The subgroup analysis showed slightly better outcomes in patients without prior interventions, although differences were not statistically significant. The stricture length did not correlate with treatment response. Optilume significantly reduces urinary symptoms and improves QoL in penile urethral strictures, and the absence of re-interventions during follow-up underscores its durable mid-term success. It offers a minimally invasive alternative to urethroplasty, particularly for patients seeking symptom relief with a shorter recovery time and no hospital stay or general anesthesia. These preliminary findings suggest that Optilume may be a promising minimally invasive option for selected patients. Larger, controlled studies are warranted to validate these results and refine patient selection criteria.
阴茎尿道狭窄是一种治疗上具有挑战性的疾病，会对生活质量产生重大影响，通常最初采用尿道扩张术或尿道内切开术进行治疗。然而，这两种技术都与高复发率、有限的长期疗效以及潜在的不良反应相关，尤其是在阴茎尿道。尿道成形术仍然是金标准，但具有侵入性，并不适用于所有患者。Optilume是一种涂有紫杉醇的球囊，它将机械扩张与局部药物递送相结合，以降低复发率和再次干预的需求。本研究评估了其在阴茎尿道狭窄患者中的有效性。在德国的两家诊所进行了一项回顾性多中心研究。八名有症状的阴茎尿道狭窄男性患者（平均年龄59岁）接受了Optilume治疗。在治疗前后使用国际前列腺症状评分（IPSS）和生活质量（QoL）评分评估症状严重程度。主要终点是症状改善，次要终点是再次干预的需求。对患者进行了中位数为16.5个月的随访。统计分析包括Wilcoxon符号秩检验和Mann-Whitney U检验。治疗后，IPSS中位数从25.5降至5.0，QoL评分从4.5降至1.0（两者均<0.01）。随访期间没有患者需要再次干预。亚组分析显示，未接受过先前干预的患者结果略好，尽管差异无统计学意义。狭窄长度与治疗反应无关。Optilume可显著减轻阴茎尿道狭窄患者的尿路症状并改善生活质量，随访期间无再次干预情况突出了其持久的中期成功。它为尿道成形术提供了一种微创替代方案，特别是对于那些寻求症状缓解、恢复时间短且无需住院或全身麻醉的患者。这些初步研究结果表明，Optilume可能是某些患者有前景的微创选择。需要进行更大规模的对照研究来验证这些结果并完善患者选择标准。
