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Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction (venogenic ED)

2026年5月22日 更新者:Hassan Ashraf、Mansoura University Hospital

Embolosclerotherapy Versus Deep Dorsal Vein Revascularization for Erectile Dysfunction Due to Venous Leak: A Randomized Clinical Study

Venous leakage is one of the causes of erectile dysfunction and can be managed using different treatment modalities, including surgical ligation and percutaneous embolization. This randomized clinical trial aims to evaluate and compare the efficacy, durability, safety, side effects, and complications of two treatment procedures-embolosclerotherapy of the periprostatic plexus and deep dorsal vein revascularization-in the management of erectile dysfunction caused by venous leak.

研究概览

详细说明

Venous leak embolization performed following an intracavernosal injection of 20 µg alprostadil with the patient positioned supine. After spinal anesthesia, a deep dorsal penile vein punctured under ultrasound guidance using a stiff 20-G micropuncture set, a 0.018-inch guidewire, and a 4-French introducer.

The introducer advanced through Buck's fascia into the deep dorsal vein, carefully positioned near the radix penis, and a diagnostic venogram obtained to confirm the presence of venous leakage.

All instruments then flushed with 0.9% saline solution. Venous embolization carried out using a slow, controlled injection of a liquid embolic agent, either ethylene-vinyl alcohol copolymer (EVOH) in DMSO with tantalum powder or a polidocanol and gel foam mixture, under continuous fluoroscopic monitoring.

The injection stopped in time to prevent unintended spread of the embolic material to the internal pudendal or periprostatic veins leading to the iliohypogastric veins, the external pudendal veins leading to the femoral veins, or the dorsal penile veins.

Penile venous arterialization performed by creating an end-to-end anastomosis between the inferior epigastric artery and the deep dorsal penile vein. The procedure begin with an infrapubic incision, through which the superficial penile veins ligated. Buck's fascia then incised and opened along the midline. A sufficient segment of the dorsal penile vein carefully dissected, and all emissary and circumflex veins in the area ligated.

The inferior epigastric artery exposed via a pararectal incision. The vascular pedicle, including its venous components, dissected superiorly up to the umbilicus-where the artery was typically divided-and inferiorly toward its origin from the femoral artery within the pelvis. All arterial branches were secured during dissection. Approximately 15-20 cm of the vessel was mobilized to ensure adequate length to reach the deep dorsal vein.

The artery was then transected and redirected to the proximal penis through a small inguinal tunnel, and controlled using vascular clamps. Subsequently, the deep dorsal penile vein divided as proximally as possible in the infrapubic region, and its proximal end was ligated. An end-to-end anastomosis then performed between the distal end of the inferior epigastric artery and the distal segment of the deep dorsal vein using interrupted 7-0 monofilament nylon sutures under loupe magnification.

Heparinized solution was used to dilate both vessels during the anastomosis, while papaverine irrigation helped prevent arterial spasm.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Cases with ED reporting difficulty in attaining or maintaining erection for at least 6 months.
  • All participants were sexually active, in a stable and heterosexual partnership, living with their sexual partner for at least the past one year, and have only one sexual partner.
  • The frequency of trying sexual intercourse was ≥1/week.
  • Unsatisfactory response to PDE5i medication.
  • All cases suffered venogenic erectile dysfunction diagnosed by color flow Doppler sonography before and after intracavernous injection of vasoactive drugs or Dynamic infusion cavernosometry-cavernosography (selected cases), which indicated veno-occlusive dysfunction.

Exclusion Criteria:

  • Refusal to participate.
  • Major psychological or psychiatric disorders.
  • Non-vascular causes of ED including penile anatomic defects, any related neurological etiology or spinal cord injury, hypogonadism and hormonal disturbances.
  • History of previous venous surgery, suspected or proven deep venous thrombosis, history of Deep Vein Thrombosis.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:endovascular emblosclerotherapy for venogenic erectile dysfunction
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
有源比较器:Revascularization of Deep dorsal vein
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
improvement in International Index of Erectile Function
大体时间:6 weeks
minimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score
6 weeks

次要结果测量

结果测量
大体时间
safety outcomes, including major adverse events classified according to the CIRSE classification system
大体时间:6 weeks
6 weeks
post-procedural pain assessed using a visual analogue scale
大体时间:6 weeks
6 weeks
patient-reported outcomes using the Patient Global Impression of Improvement
大体时间:6 weeks
6 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mosaad A Soliman, MD, PhD、vascular surgery department, faculty of medicine, mansoura university
  • 学习椅:khaled A mowafy, MD, PhD、vascular surgery department, faculty of medicine, mansoura university
  • 学习椅:Reem M Soliman, MD, PhD、vascular surgery department, faculty of medicine, mansoura university
  • 学习椅:Ahmed Azhar, MD, PhD, FACS、vascular surgery department, faculty of medicine, mansoura university

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月20日

初级完成 (估计的)

2027年5月20日

研究完成 (估计的)

2027年9月20日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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