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Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction

NCT04345965 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-12-28

No results posted yet for this study

Summary

Brief Summary:

Background and pathophysiology: Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.

ED is not in itself a "serious" disease, but its impact on quality of life is extremely important, affecting the family and interpersonal relationships.

Male erection is a complex mechanism that involves neuro-vascular tissue responses with several phases including arterial dilatation, smooth muscle cells relaxation and ultimately veno-occlusive activation.

Vasculogenic erectile dysfunction can be divided in arteriogenic (when there is insufficiency of arterial component of erection due to atherosclerotic plaque encroachment of the penile arteries) or venogenic (where there is insufficiency of the venous component of erection for venous endoleak) Standard treatment Erectile dysfunction is commonly treated by oral phosphodiesterase-5-inhibitor (PDE5i) administration. However, up to 50% of men have a suboptimal response to PDE5-i therapy with the need of additional therapies. New treatment Only recently several studies have been published on percutaneous treatment of ED using plain old balloon angioplasty (POBA), Drug eluting balloons (both paclitaxel and sirolimus, PEB and SES) and drug eluting stents (DES).

Aim of the study: Evaluation of the safety and feasibility of sirolimus drug eluting balloon treatment in focal atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and a no response to phosphodiesterase-5 inhibitors.

Conditions

Interventions

PROCEDURE

Endovascular procedure

Endovascular therapies for erectile dysfunction

Sponsors & Collaborators

  • Clinica San Gaudenzio

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345965 on ClinicalTrials.gov