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Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07604194
Acronym
venogenic ED
Enrollment
60
Registered
2026-05-22
Start date
2026-06-20
Completion date
2027-09-20
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)

Keywords

Venogenic erectile dysfunction, Onyx, Endovascular embolization, Venous leak, deep dorsal vein, revascularization, polidocanol

Brief summary

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.

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.

Interventions

PROCEDUREEndovascular embolosclerotherapy

The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.

PROCEDURERevacularization of deep dorsal vein

Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery

Sponsors

Mansoura University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
improvement in International Index of Erectile Function6 weeksminimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score

Secondary

MeasureTime frame
safety outcomes, including major adverse events classified according to the CIRSE classification system6 weeks
post-procedural pain assessed using a visual analogue scale6 weeks
patient-reported outcomes using the Patient Global Impression of Improvement6 weeks

Contacts

CONTACTHassan A Hassan, MD
hassan3ash1996@gmail.com+201116043210
CONTACTMosaad A Soliman, MD, PhD
soliman_mosaad@hotmail.com+201001535711
PRINCIPAL_INVESTIGATORMosaad A Soliman, MD, PhD

vascular surgery department, faculty of medicine, mansoura university

STUDY_CHAIRkhaled A mowafy, MD, PhD

vascular surgery department, faculty of medicine, mansoura university

STUDY_CHAIRReem M Soliman, MD, PhD

vascular surgery department, faculty of medicine, mansoura university

STUDY_CHAIRAhmed Azhar, MD, PhD, FACS

vascular surgery department, faculty of medicine, mansoura university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026