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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hassan A Hassan, MD
- Número de teléfono: +201116043210
- Correo electrónico: hassan3ash1996@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Mosaad A Soliman, MD, PhD
- Número de teléfono: +201001535711
- Correo electrónico: soliman_mosaad@hotmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
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Comparador activo: Revascularization of Deep dorsal vein
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
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Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
improvement in International Index of Erectile Function
Periodo de tiempo: 6 weeks
|
minimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
safety outcomes, including major adverse events classified according to the CIRSE classification system
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
post-procedural pain assessed using a visual analogue scale
Periodo de tiempo: 6 weeks
|
6 weeks
|
|
patient-reported outcomes using the Patient Global Impression of Improvement
Periodo de tiempo: 6 weeks
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mosaad A Soliman, MD, PhD, vascular surgery department, faculty of medicine, mansoura university
- Silla de estudio: khaled A mowafy, MD, PhD, vascular surgery department, faculty of medicine, mansoura university
- Silla de estudio: Reem M Soliman, MD, PhD, vascular surgery department, faculty of medicine, mansoura university
- Silla de estudio: Ahmed Azhar, MD, PhD, FACS, vascular surgery department, faculty of medicine, mansoura university
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R.26.04.3667
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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