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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endovascular emblosclerotherapy for venogenic erectile dysfunction | Experimental | The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins. |
|
| Revascularization of Deep dorsal vein | Active Comparator | Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular embolosclerotherapy | Procedure | The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins. |
| 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hassan A Hassan, MD | Contact | +201116043210 | hassan3ash1996@gmail.com | |
| Mosaad A Soliman, MD, PhD | Contact | +201001535711 | soliman_mosaad@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mosaad A Soliman, MD, PhD | vascular surgery department, faculty of medicine, mansoura university | Principal Investigator |
| khaled A mowafy, MD, PhD | vascular surgery department, faculty of medicine, mansoura university |
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| Revacularization of deep dorsal vein | Procedure | Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery |
|
| patient-reported outcomes using the Patient Global Impression of Improvement |
| 6 weeks |
| 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 Chair |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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