An observational study in Erectile Dysfunction, sponsored by Clinica San Gaudenzio. Completed at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by Clinica San Gaudenzio · Observational
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.
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 300 is above the median of 130 across 115 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Clinica San Gaudenzio is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment
Exclusion Criteria:
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
IEF-5 SCORE VARIATION AFTER ENDOVASCULAR
INTERNATIONAL INDEX OF ERECTILE FUNCTION
Time frame: 6 months
PSV VARIATION AFTER ENDOVASCULAR TREATMENT
PUDENDAL DOPPLER PEAK SYSTOLIC VELOCITY
Time frame: 6 month
ADVERSE EVENTS
Procedural complications; cardiovascular events during follow-up
Time frame: 6-12 months
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Clinica San Gaudenzio