NCT07604194

Brief 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 procedures-embolosclerotherapy of the periprostatic plexus and deep dorsal vein revascularization-in the management of erectile dysfunction caused by venous leak.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Erectile Dysfunction Due to Venous DisorderErectile Dysfunction (ED)

Keywords

Venogenic erectile dysfunctionOnyxEndovascular embolizationVenous leakdeep dorsal veinrevascularizationpolidocanol

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • patient-reported outcomes using the Patient Global Impression of Improvement

    6 weeks

Study Arms (2)

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.

Procedure: Endovascular embolosclerotherapy

Revascularization of Deep dorsal vein

ACTIVE COMPARATOR

Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery

Procedure: Revacularization of deep dorsal vein

Interventions

Endovascular embolosclerotherapyPROCEDURE

The goal of endovascular therapy is to achieve adequate embolization of efferent pelvic veins, including the periprostatic and internal or external pudendal veins.

endovascular emblosclerotherapy for venogenic erectile dysfunction
Revacularization of deep dorsal veinPROCEDURE

Penile venous arterialization of the Deep Dorsal vein using inferior epigastric artery

Revascularization of Deep dorsal vein

Eligibility Criteria

Age40 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • 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

    STUDY CHAIR

  • 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

Central Study Contacts

Hassan A Hassan, MD

CONTACT

+201116043210hassan3ash1996@gmail.com

Mosaad A Soliman, MD, PhD

CONTACT

+201001535711soliman_mosaad@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

September 20, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05