Venous leakage ED: embolosclerotherapy vs deep dorsal vein revascularization
Official title: Embolosclerotherapy Versus Deep Dorsal Vein Revascularization for Erectile Dysfunction Due to Venous Leak: A Randomized Clinical Study
Run by Mansoura University Hospital · NCT07604194 · Data updated 2026-11-12
This trial tests whether embolizing the veins around the penis or reconstructing the deep dorsal vein helps men with erectile dysfunction caused by venous leaks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | Mansoura University Hospital Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Status | Recruiting |
| Started | June 20, 2026 |
| Main results expected | May 20, 2027 |
| Study ends | September 20, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07604194 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult men with venogenic erectile dysfunction due to venous leak, sexually active with a stable partner, and inadequate response to PDE5 inhibitors.
✕Probably not a fit
Men whose ED is not primarily venous in origin or who have significant non-vascular causes of erectile dysfunction may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized study compares two endovascular and surgical approaches for venogenic erectile dysfunction: embolosclerotherapy of the periprostatic venous plexus and revascularization of the deep dorsal vein. Participants have venogenic ED with insufficient response to PDE5 inhibitors and confirmed venous leak. Procedures are performed under imaging guidance with careful embolic material selection and intraoperative venograms to minimize non-target spread. Outcomes focus on efficacy, durability, safety, and any procedure-related complications. The trial is conducted at Mansoura University Hospital and aims to determine which approach provides more reliable improvement in erectile function over time.
Why it matters
Potential benefit: If successful, patients may experience improved erectile function with a durable response and potentially fewer medication requirements.
How similar studies have gone: Previous approaches for venous leak treatment have shown variable success; this study tests two distinct strategies in a randomized design to clarify benefit.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Mansoura University hospital
Al Mansurah, Dakahlia Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Mosaad A Soliman, MD, PhD — vascular surgery department, faculty of medicine, mansoura university
- Study coordinator: Hassan A Hassan, MD
- Email: hassan3ash1996@gmail.com
- Phone: +201116043210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.