An interventional study of Endovascular embolosclerotherapy and Revacularization of deep dorsal vein in Erectile Dysfunction Due to Venous Disorder and Erectile Dysfunction (ED), sponsored by Mansoura University Hospital. Recruiting at 1 site in Egypt. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Mansoura University Hospital · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
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Exclusion Criteria:
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
Procedure: Endovascular embolosclerotherapy
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
Procedure: Revacularization of deep dorsal vein
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
improvement in International Index of Erectile Function
minimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score
Time frame: 6 weeks
safety outcomes, including major adverse events classified according to the CIRSE classification system
Time frame: 6 weeks
post-procedural pain assessed using a visual analogue scale
Time frame: 6 weeks
patient-reported outcomes using the Patient Global Impression of Improvement
Time frame: 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Mansoura University Hospital