Endovascular Therapy for Erectile Dysfunction

NCT04333173 | Completed DMC

• 1 other identifier: 101010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Background and pathophysiology Erectile dysfunction is a serious disease with a significant impact on the quality of life. 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-inhbitor (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 POBA, Drug eluting balloons (both paclitaxel and sirolimus, PEB and SES) and drug eluting stents (DES). Aim of the study The study was aimed at evaluating both arteriogenic and venogenic endovascular treatments in patients affected by erectile dysfunction in an Italian patient cohort.

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (1)

• IEF-5 SCORE VARIATION AFTER ENDOVASCULAR

  INTERNATIONAL INDEX OF ERECTILE FUNCTION

  6 months

Secondary Outcomes (2)

• PSV VARIATION AFTER ENDOVASCULAR TREATMENT

  6 month

• ADVERSE EVENTS

  6-12 months

Study Arms (1)

Active endovascular treatment

Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment

Procedure: endovascular procedure

Interventions

endovascular procedure PROCEDURE

Endovascular therapies for erectile dysfunction

Active endovascular treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment

You may qualify if:

• Age \> 18 years old
• Be able to understand and sign a witnessed informed consent for the procedure
• Eligibility for percutaneous peripheral intervention
• Baseline IIEF-5 score evaluation \< 15
• PSV \< 25 cm/sec
• Stable hemodynamic conditions
• Normal ejection fraction
• Being refractory to oral PDE5-I for at least 6 months before enrollement
• Treatable angiographic lesions of the pudendal arteries

You may not qualify if:

• Heart failure
• Hemodynamic instability
• Basal IIEF-5 and doppler examination
• Blood count not within normal ranges
• No history of bleeding or coagulopathy
• No other serious medical illness
• Other investigational drug or device study
• Pudendal artery \< 1.5 mm and lesion lenght greater than 80 mm by visual estimation
• Pudendal restenosis from previous intervention

Sponsors & Collaborators

• Clinica San Gaudenzio: lead

Study Sites (1)

Centro Cuore

Novara, Italy

Location

Related Publications (3)

• Sangiorgi G, Colantonio R, Antonini G, Savino A, Sperandio M. [Percutaneous intervention therapy for vascular erectile dysfunction]. G Ital Cardiol (Rome). 2016 Oct;17(10 Suppl 1):12S-21. doi: 10.1714/2372.25474. Italian.

  PMID: 27729664 BACKGROUND

• Doppalapudi SK, Wajswol E, Shukla PA, Kolber MK, Singh MK, Kumar A, Fischman A, Rastinehad AR. Endovascular Therapy for Vasculogenic Erectile Dysfunction: A Systematic Review and Meta-Analysis of Arterial and Venous Therapies. J Vasc Interv Radiol. 2019 Aug;30(8):1251-1258.e2. doi: 10.1016/j.jvir.2019.01.024. Epub 2019 May 17.

  PMID: 31104902 BACKGROUND

• Diehm N, Marggi S, Ueki Y, Schumacher D, Keo HH, Regli C, Do DD, Moeltgen T, Grimsehl P, Wyler S, Schoenhofen H, Raber L, Schumacher M. Endovascular Therapy for Erectile Dysfunction-Who Benefits Most? Insights From a Single-Center Experience. J Endovasc Ther. 2019 Apr;26(2):181-190. doi: 10.1177/1526602819829903. Epub 2019 Feb 11.

  PMID: 30741067 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Endovascular Procedures

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: February 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)