Endovascular Therapy for Erectile Dysfunction
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 03/31/2020 |
| Estimated Enrollment Submitted: | 03/31/2020 |
| First Posted: | 04/02/2020 |
| Last Update Submitted: | 03/31/2020 |
| Last Update Posted: | 04/02/2020 |
| Actual Study Start Date: | 01/31/2017 |
| Estimated Primary Completion Date: | 12/31/2019 |
| Estimated Study Completion Date: | 12/31/2019 |
Condition or disease
Intervention/treatment
Procedure: Active endovascular treatment
Phase
Arm Groups
| Arm | 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: Active endovascular treatment Endovascular therapies for erectile dysfunction |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | No |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. IEF-5 SCORE VARIATION AFTER ENDOVASCULAR [6 months]
Secondary Outcome Measures
1. PSV VARIATION AFTER ENDOVASCULAR TREATMENT [6 month]
2. ADVERSE EVENTS [6-12 months]
