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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction Due to Venous Disorder; Erectile Dysfunction (ED)
• Intervention / Treatment: Procedure: Endovascular embolosclerotherapy; Procedure: Revacularization of deep dorsal vein

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hassan A Hassan, MD; Phone Number: +201116043210; Email: hassan3ash1996@gmail.com
• Study Contact Backup: Name: Mosaad A Soliman, MD, PhD; Phone Number: +201001535711; Email: soliman_mosaad@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Endovascular embolosclerotherapy; The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
Active Comparator: Revascularization of Deep dorsal vein; Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery	Procedure: Revacularization of deep dorsal vein; Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
safety outcomes, including major adverse events classified according to the CIRSE classification system	6 weeks
post-procedural pain assessed using a visual analogue scale	6 weeks
patient-reported outcomes using the Patient Global Impression of Improvement	6 weeks

Collaborators and Investigators

• Sponsor: Mansoura University Hospital
• Investigators: Principal Investigator: Mosaad A Soliman, MD, PhD, vascular surgery department, faculty of medicine, mansoura university; Study Chair: khaled A mowafy, MD, PhD, vascular surgery department, faculty of medicine, mansoura university; Study Chair: Reem M Soliman, MD, PhD, vascular surgery department, faculty of medicine, mansoura university; Study Chair: Ahmed Azhar, MD, PhD, FACS, vascular surgery department, faculty of medicine, mansoura university

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): September 20, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: revascularization; Onyx; polidocanol; Venogenic erectile dysfunction; Endovascular embolization; Venous leak; deep dorsal vein
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: R.26.04.3667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No