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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hassan A Hassan, MD
- Telefoonnummer: +201116043210
- E-mail: hassan3ash1996@gmail.com
Studie Contact Back-up
- Naam: Mosaad A Soliman, MD, PhD
- Telefoonnummer: +201001535711
- E-mail: soliman_mosaad@hotmail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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improvement in International Index of Erectile Function
Tijdsspanne: 6 weeks
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minimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score
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6 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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safety outcomes, including major adverse events classified according to the CIRSE classification system
Tijdsspanne: 6 weeks
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6 weeks
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post-procedural pain assessed using a visual analogue scale
Tijdsspanne: 6 weeks
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6 weeks
|
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patient-reported outcomes using the Patient Global Impression of Improvement
Tijdsspanne: 6 weeks
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6 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mosaad A Soliman, MD, PhD, vascular surgery department, faculty of medicine, mansoura university
- Studie stoel: khaled A mowafy, MD, PhD, vascular surgery department, faculty of medicine, mansoura university
- Studie stoel: Reem M Soliman, MD, PhD, vascular surgery department, faculty of medicine, mansoura university
- Studie stoel: Ahmed Azhar, MD, PhD, FACS, vascular surgery department, faculty of medicine, mansoura university
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R.26.04.3667
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