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Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction

ConditionsErectile Dysfunction Due to Venous DisorderErectile Dysfunction (ED)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-80
SponsorMansoura University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Endovascular embolosclerotherapy

    Procedure/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 vein

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: endovascular emblosclerotherapy for venogenic erectile dysfunctionExperimental treatment 1 intervention
Group B: Revascularization of Deep dorsal veinActive comparator 1 intervention

Trial outcomes

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

Time frame
6 weeks

Secondary outcomes

1

safety outcomes, including major adverse events classified according to the CIRSE classification system

Time frame
6 weeks
2

post-procedural pain assessed using a visual analogue scale

Time frame
6 weeks
3

patient-reported outcomes using the Patient Global Impression of Improvement

Time frame
6 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: