Erectile Dysfunction Due to Arterial DiseasePD and VODNCT05311748
Prospective Cross-sectional Evaluation of Penile Helicine Circulation in Veno-occlusive Erectile Dysfunction
An observational study of Erectile Dysfunction Due to Arterial Disease, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to improve the diagnostic work up of veno-occlusive erectile dysfunction patients. Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Arterial Disease
- What is being tested?
- Ultrasound and doppler
- How many people
- 202 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Jan 2014to 15 Jul 2019
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients affected by erectile dysfunction for at least 6 months
Who may be able to join
- Erectile dysfunction
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Urology Unit, Sapienza University of Rome
Latina, 04100
Alessandro Zucchi
Pisa
About this study
Official title: Prospective Cross-sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-occlusive Erectile Dysfunction
Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to improve the diagnostic work up of veno-occlusive erectile dysfunction patients.
Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional study. All patients underwent Dynamic Power Doppler after intracevernous injection of vasoactive drugs. Poor responders patients subsequently underwent to cavernosometry to get a full assessment of the vascular framework.
Read the detailed description
Veno-occlusive continence is linked both to the integrity of neurological, vascular, and endocrine structures and to the fibro-elastic characteristics of the cavernous tissue. In most subjects with Erectile Dysfunction (ED), the erectile tissue presents histological alterations such as the reduction of smooth muscle cells and the increased deposition of connective tissue. A hypothesis describes these changes as promotors for the onset of veno-occlusive dysfunction (VOD).
Dynamic cavernosometry, supplemented by contrast cavernosography, still represents the gold standard for the diagnosis of VOD allowing the visualization of the competent venous districts. These investigations, which had moderate popularity in the 1980s and underwent several variations in the methodology of execution, are rarely used today due to their invasiveness, the need for dedicated instruments and the scarce success of commonly adopted surgical treatments (vein ligation surgery).
The recent introduction of endovascular techniques sheds new light on the correct classification of vascular ED, especially in those patients with a sub-optimal response to the use of drug therapy as an alternative to prosthetic surgery.
Advances in imaging techniques, including Power Doppler (PD) ultrasonography, allow an accurate and complete study of penile circulation including the study of low-flow vessels.
The introduction of PD, during the penile duplex ultrasound routinely performed, had additionally permitted the extension of the field of the study into the arteriolar circulation of the corpora cavernosa, making possible the assessment of the vessels with a "low speed flow", like the helicine arteries, which escape the standard Doppler Pulsated evaluation; especially during the phases of the penile tumescence and partial rigidity, phases 1-2, according to Erection Hardness Score .
From an anatomical and vascular point of view, the helicine arteries usually describe an acute angle with the cavernous artery, delineating a Cavernous Terminal Unit (CTU).
The dynamic penile echo-color-doppler ultrasound can evaluate the correct assessment of the CTU, by applying the PD function. In fact, the PD module, with calibration of the pulse repetition frequency (PRF) of the transducer at 700 HZ applied to the cavernous arteries in the dynamic phase, allows the study of the ramifications of the arteries up to the 3rd order and their inclination in relation to the main trunk, expression or not of the integrity of the CTU. In this contest, PD applied to dynamic penile duplex ultrasound, has established itself as a method potentially suitable in the assessment of patients with VOD.
- Being tested
- Ultrasound and doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and dopplerDiagnostic test
Penile echocolour doppler ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25).
Every subject will be studied by penile ultrasound with color doppler
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 Jan 2014
- Primary completion13 Mar 2017
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile Dysfunction Due to Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa
- Responsible party
- Principal investigator, Antonio Luigi Pastore, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311748
- Sponsor's protocol ID
- UrolUNIVPISA
- Acronym
- PD and VOD
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim N, Azadzoi KM, Goldstein I, Saenz de Tejada I. A nitric oxide-like factor mediates nonadrenergic-noncholinergic neurogenic relaxation of penile corpus cavernosum smooth muscle. J Clin Invest. 1991 Jul;88(1):112-8. doi: 10.1172/JCI115266.
PubMed 1647413
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cross-sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-occlusive Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05311748
- Acronym / sponsor ID
- PD and VOD / UrolUNIVPISA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University of Pisa
- Study start
- 15 Jan 2014 (actual)
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 5 Apr 2022 (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.
Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to improve the diagnostic work up of veno-occlusive erectile dysfunction patients.
Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional study. All patients underwent Dynamic Power Doppler after intracevernous injection of vasoactive drugs. Poor responders patients subsequently underwent to cavernosometry to get a full assessment of the vascular framework.
Detailed description
Veno-occlusive continence is linked both to the integrity of neurological, vascular, and endocrine structures and to the fibro-elastic characteristics of the cavernous tissue. In most subjects with Erectile Dysfunction (ED), the erectile tissue presents histological alterations such as the reduction of smooth muscle cells and the increased deposition of connective tissue. A hypothesis describes these changes as promotors for the onset of veno-occlusive dysfunction (VOD).
Dynamic cavernosometry, supplemented by contrast cavernosography, still represents the gold standard for the diagnosis of VOD allowing the visualization of the competent venous districts. These investigations, which had moderate popularity in the 1980s and underwent several variations in the methodology of execution, are rarely used today due to their invasiveness, the need for dedicated instruments and the scarce success of commonly adopted surgical treatments (vein ligation surgery).
The recent introduction of endovascular techniques sheds new light on the correct classification of vascular ED, especially in those patients with a sub-optimal response to the use of drug therapy as an alternative to prosthetic surgery.
Advances in imaging techniques, including Power Doppler (PD) ultrasonography, allow an accurate and complete study of penile circulation including the study of low-flow vessels.
The introduction of PD, during the penile duplex ultrasound routinely performed, had additionally permitted the extension of the field of the study into the arteriolar circulation of the corpora cavernosa, making possible the assessment of the vessels with a "low speed flow", like the helicine arteries, which escape the standard Doppler Pulsated evaluation; especially during the phases of the penile tumescence and partial rigidity, phases 1-2, according to Erection Hardness Score .
From an anatomical and vascular point of view, the helicine arteries usually describe an acute angle with the cavernous artery, delineating a Cavernous Terminal Unit (CTU).
The dynamic penile echo-color-doppler ultrasound can evaluate the correct assessment of the CTU, by applying the PD function. In fact, the PD module, with calibration of the pulse repetition frequency (PRF) of the transducer at 700 HZ applied to the cavernous arteries in the dynamic phase, allows the study of the ramifications of the arteries up to the 3rd order and their inclination in relation to the main trunk, expression or not of the integrity of the CTU. In this contest, PD applied to dynamic penile duplex ultrasound, has established itself as a method potentially suitable in the assessment of patients with VOD.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients affected by erectile dysfunction for at least 6 months
Key inclusion criteria (1 listed)
- Erectile dysfunction
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Ultrasound and dopplerPenile echocolour doppler ultrasound | Diagnostic test | – |
Primary outcome
Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25).
Time frame: 90 days
Every subject will be studied by penile ultrasound with color doppler
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 5 Apr 2022.
- Results publication: PubMed 1647413Kim N, Azadzoi KM, Goldstein I, Saenz de Tejada I. A nitric oxide-like factor mediates nonadrenergic-noncholinergic neurogenic relaxation of penile corpus cavernosum smooth muscle. J Clin Invest. 1991 Jul;88(1):112-8. doi: 10.1172/JCI115266.
- 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.
2 sites 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 Due to Arterial Disease, run by University of Roma La Sapienza at 2 sites 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 1 inclusion and 1 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25). (time frame: 90 days). 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 NCT05311748, which also lists 1 linked publication.
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 5 Apr 2022.