Erectile DysfunctionRE-ACTIONNCT04333173
Endovascular Therapy for Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Clinica San Gaudenzio at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- endovascular procedure
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Study population: Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment
Who may be able to join
- 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
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- Normal ejection fraction
- Being refractory to oral PDE5-I for at least 6 months before enrollement
- Treatable angiographic lesions of the pudendal arteries
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- endovascular procedure
- Keywords
- ED
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular procedureProcedure or surgery
Endovascular therapies for erectile dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Active endovascular treatment | Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment Receives: Procedure: endovascular procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
IEF-5 SCORE VARIATION AFTER ENDOVASCULAR
INTERNATIONAL INDEX OF ERECTILE FUNCTION
Measured: 6 months
Secondary outcomes (2)
PSV VARIATION AFTER ENDOVASCULAR TREATMENT
PUDENDAL DOPPLER PEAK SYSTOLIC VELOCITY
Measured: 6 month
ADVERSE EVENTS
Procedural complications; cardiovascular events during follow-up
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Feb 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica San Gaudenzio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sangiorgi, Clinica San Gaudenzio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333173
- Sponsor's protocol ID
- 101010
- Acronym
- RE-ACTION
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27729664Doppalapudi 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.
PubMed 31104902Diehm 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.
PubMed 30741067
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOVASCULAR THERAPY REGISTRY FOR ERECTILE DYSFUNCTION
- ClinicalTrials.gov ID
- NCT04333173
- Acronym / sponsor ID
- RE-ACTION / 101010
- Conditions
- Erectile Dysfunction
- Keywords
- ED
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Clinica San GaudenzioUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active endovascular treatment | – | Procedure: endovascular procedurePatients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients with erectile dysfunction (ED) and no-response to phosphodiesterase-5 inhibitors for at least 6 months before enrollment
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Heart failure
- Hemodynamic instability
- Basal IIEF-5 and doppler examination
- Blood count not within normal ranges
- No history of bleeding or coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular procedureEndovascular therapies for erectile dysfunction | Procedure or surgery | Active endovascular treatment |
Primary outcome
IEF-5 SCORE VARIATION AFTER ENDOVASCULAR
Time frame: 6 months
INTERNATIONAL INDEX OF ERECTILE FUNCTION
2 secondary outcomes
PSV VARIATION AFTER ENDOVASCULAR TREATMENT
Time frame: 6 month
ADVERSE EVENTS
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 27729664Sangiorgi 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.
- Background: PubMed 31104902Doppalapudi 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.
- Background: PubMed 30741067Diehm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Clinica San Gaudenzio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IEF-5 SCORE VARIATION AFTER ENDOVASCULAR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333173, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.