Erectile Dysfunction Due to Venous Disordervenogenic EDNCT07604194
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction
A study testing Endovascular embolosclerotherapy and Revacularization of deep dorsal vein in people with Erectile Dysfunction Due to Venous Disorder and Erectile Dysfunction (ED), run by Mansoura University Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)
- What is being tested?
- Endovascular embolosclerotherapy and Revacularization of deep dorsal vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2026to 20 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University hospital
Al Mansurah, Dakahlia Governorate, 35511
Hassan Hassan, 00201116043210, hassan3ash1996@gmail.com
About this study
Official title: Embolosclerotherapy Versus Deep Dorsal Vein Revascularization for Erectile Dysfunction Due to Venous Leak: A Randomized Clinical Study
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.
Read the 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.
- Being tested
- Endovascular embolosclerotherapy, Revacularization of deep dorsal vein
- Keywords
- Venogenic erectile dysfunction, Onyx, Endovascular embolization, Venous leak, deep dorsal vein, revascularization, polidocanol
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular embolosclerotherapyProcedure or surgery
The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.
Revacularization of deep dorsal veinProcedure or surgery
Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endovascular embolosclerotherapy |
| Revascularization of Deep dorsal vein | Active comparator | Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery Receives: Procedure: Revacularization of deep dorsal vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
safety outcomes, including major adverse events classified according to the CIRSE classification system
Measured: 6 weeks
post-procedural pain assessed using a visual analogue scale
Measured: 6 weeks
patient-reported outcomes using the Patient Global Impression of Improvement
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 Jun 2026
- Primary completion20 May 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Due to Venous DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Ashraf, Mansoura University Hospital
- Investigators
- Mosaad A Soliman, MD, PhD, Principal investigator, vascular surgery department, faculty of medicine, mansoura universitykhaled A mowafy, MD, PhD, Study chair, vascular surgery department, faculty of medicine, mansoura universityReem M Soliman, MD, PhD, Study chair, vascular surgery department, faculty of medicine, mansoura universityAhmed Azhar, MD, PhD, FACS, Study chair, vascular surgery department, faculty of medicine, mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604194
- Sponsor's protocol ID
- R.26.04.3667
- Acronym
- venogenic ED
- Status last verified
- Oct 2026
- First submitted
- 18 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolosclerotherapy Versus Deep Dorsal Vein Revascularization for Erectile Dysfunction Due to Venous Leak: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07604194
- Acronym / sponsor ID
- venogenic ED / R.26.04.3667
- Keywords
- Venogenic erectile dysfunction, Onyx, Endovascular embolization, Venous leak, deep dorsal vein, revascularization, polidocanol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endovascular emblosclerotherapy for venogenic erectile dysfunction | Experimental | Procedure: Endovascular embolosclerotherapyThe 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 | Procedure: Revacularization of deep dorsal veinPenile venous arterialization of the Deep Dorsal vein using inferior epigastric artery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular embolosclerotherapyThe goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins. | Procedure or surgery | endovascular emblosclerotherapy for venogenic erectile dysfunction |
| Revacularization of deep dorsal veinPenile venous arterialization of the Deep Dorsal vein using inferior epigastric artery | Procedure or surgery | Revascularization of Deep dorsal vein |
Primary outcome
improvement in International Index of Erectile Function
Time frame: 6 weeks
minimal clinically important difference, defined as a ≥4-point increase in the EF domain of the IIEF score
3 secondary outcomes
safety outcomes, including major adverse events classified according to the CIRSE classification system
Time frame: 6 weeks
post-procedural pain assessed using a visual analogue scale
Time frame: 6 weeks
patient-reported outcomes using the Patient Global Impression of Improvement
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mosaad A Soliman, MD, PhD principal investigator
vascular surgery department, faculty of medicine, mansoura university
khaled A mowafy, MD, PhD study chair
vascular surgery department, faculty of medicine, mansoura university
Reem M Soliman, MD, PhD study chair
vascular surgery department, faculty of medicine, mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular embolosclerotherapy and Revacularization of deep dorsal vein in people with Erectile Dysfunction Due to Venous Disorder and Erectile Dysfunction (ED), run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassan A Hassan, MD (+201116043210, hassan3ash1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in International Index of Erectile Function (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.