Erectile Dysfunction Clinical Trial
— RE-ACTIONOfficial title:
ENDOVASCULAR THERAPY REGISTRY FOR ERECTILE DYSFUNCTION
NCT number | NCT04333173 |
Other study ID # | 101010 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2017 |
Est. completion date | January 1, 2020 |
Verified date | April 2020 |
Source | Clinica San Gaudenzio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 300 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Centro Cuore | Novara |
Lead Sponsor | Collaborator |
---|---|
Clinica San Gaudenzio |
Italy,
Diehm N, Marggi S, Ueki Y, Schumacher D, Keo HH, Regli C, Do DD, Moeltgen T, Grimsehl P, Wyler S, Schoenhofen H, Räber 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. — View Citation
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. — View Citation
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. Review. Italian. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IEF-5 SCORE VARIATION AFTER ENDOVASCULAR | INTERNATIONAL INDEX OF ERECTILE FUNCTION | 6 months | |
Secondary | PSV VARIATION AFTER ENDOVASCULAR TREATMENT | PUDENDAL DOPPLER PEAK SYSTOLIC VELOCITY | 6 month | |
Secondary | ADVERSE EVENTS | Procedural complications; cardiovascular events during follow-up | 6-12 months |
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