Endovascular Therapy for Erectile Dysfunction (RE-ACTION)

ENDOVASCULAR THERAPY REGISTRY FOR ERECTILE DYSFUNCTION

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Procedure: endovascular procedure

Detailed Description

Detailed Description: The objective of this study is to evaluate of the safety and feasibility of endovascular therapies in segmental atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months either at increasing dosage or with different drugs routinely utilized in this setting) before enrollment. All patients will be screened by IIEF-5 questionnaire (IEF-5 Score < 15 points); Penile Dynamic Doppler ultrasound with intracavernous injection of Caverject (cut-off for Inflow insufficiency: PSV <25 cm s-1, EDV <5 cm s-1, RI > 0.8; cut-off for Venous leakage: PSV > 25 cm s-1, EDV > 5 cm s-1, RI < 0.8; cut-off for mixed pathology: PSV < 25 cm s-1, EDV > 5 cm s-1, RI < 0.8); and/or positive angio-CT scan for stenosis of the penile arteries of venous insufficiency. All patients will be treated either by POBA+PES/SES or in case of suboptimal result (angiographic residual stenosis > 30%) with DES implantation. All patients will be discharged with dual antiplatelet therapy for 3 months and with Cialis 5 mg daily for 30 days. Patients will be followed at 1 mos with IIEF questionnaire, 3 months with IIE-5 questionnaire, 8 months with IIEF questionnaire and Dynamic Doppler ultrasound evaluation, and 12 months with IIEF-5 questionnaire and Dynamic Doppler ultrasound evaluation. Primary endpoints will be the delta of IEF-5 score between basal and 8 months FU (>5 points). Delta PSV (>8 points of cm/sec at the Dynamic Doppler evaluation) between basal and 8 mos follow-up. 1. Secondary endpoints will be a) Incidence of MAE (Death, MI, Stroke), 2) Binary restenosis and late loss in patients who will repeat control angiography if clinically indicated for ED recurrence (clinically evaluated by either needs to reintroduce/increase PDEF5i dosage on-demand, delta IEF-5 <5 compared to 1 mos FU after 6 mos FU) or in patients with bilateral disease with scheduled procedure after 6 mos FU from the index procedure.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Italy
  • Novara, Italy
    • Centro Cuore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Endovascular therapies for erectile dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IEF-5 SCORE VARIATION AFTER ENDOVASCULAR	INTERNATIONAL INDEX OF ERECTILE FUNCTION	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSV VARIATION AFTER ENDOVASCULAR TREATMENT	PUDENDAL DOPPLER PEAK SYSTOLIC VELOCITY	6 month
ADVERSE EVENTS	Procedural complications; cardiovascular events during follow-up	6-12 months

Collaborators and Investigators

• Sponsor: Clinica San Gaudenzio

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: ED
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: 101010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No