Erectile DysfunctionNCT04399057
Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction
An observational study of Erectile Dysfunction and Penile Diseases, run by University Of Perugia at 1 site in Italy.
Trial summary
the study proposes the use of a new non-invasive ultrasound method for the diagnosis of erectile dysfunction. in particular, the shear Wave elastosonosgraphy of the corpora cavernosa will be used. this last method quantitatively measures the rigidity of the analyzed tissues. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction, Penile Diseases
- What is being tested?
- shear Wave Elastosonography
- How many people
- 322 participants
- Where
- 1 siteItaly
- Study dates
- 13 May 2020to 31 May 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 to 80 years
- Men only
- Adult, Older adult
Study population: the population chosen is male, who goes to the clinics for andrological problems.
Who may be able to join
- male who came attended our general andrology clinic between January 2019 to January 2020.
Who cannot join
- with: age >80 years or <18 years. , 2
- diabetes,
- spinal trauma,
- treatment with continuous PDE5i,
- ischemic heart disease for less than 6 months,
- pelvic surgery for within less than 1 year,
Show all 9Show fewer
- hypotestosteronemia (<8 nmol/L),
- La Peyronie's disease.
- penile trauma.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Elisabetta Costantini
Terni, 05100
Elisabetta Costantini, Professor, 3283620614, elisabetta.costantini@unipg.it
Ester Illiano, MD, 3283620614, ester.illiano@inwind.it
About this study
Official title: a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.
the study proposes the use of a new non-invasive ultrasound method for the diagnosis of erectile dysfunction. in particular, the shear Wave elastosonosgraphy of the corpora cavernosa will be used. this last method quantitatively measures the rigidity of the analyzed tissues.
Read the detailed description
erectile function is a complex mechanism in which the elasticity of the tissues that make up the corpora cavernosa is fundamental. indeed, anatomopathological studies have shown that in patients with erectile dysfunction the elastic fibers are replaced by inextensible collagen. the aim of the study is the correlation between penile stiffness measured with this new non-invasive diagnostic method - elastosonography of the corpora cavernosa - and the correlation with validated questionnaires. the international Index of Erectile Function (IIEF5) short form and the erectile Hardness Score (EHS) will be used.
- Conditions
- Erectile Dysfunction, Penile Diseases
- Being tested
- shear Wave Elastosonography
- Keywords
- erectile dysfunction, elastosonography, penile diseases, International index of erectile function, erectile hardness score
- Medical subject headings
- Erectile Dysfunction, Penile Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shear Wave ElastosonographyDiagnostic test
both the left cavernous body and the right cavernous body are ideally divided longitudinally into three sections: proximal, middle and distal. subsequently for each section of the corpora cavernosa the stiffness of the tissue is calculated by means of a specific Region Of Interest (ROI). the result is expressed in Kilopascals and in a color scale. when registering the stiffness the patient is asked to hold their breath.
| Study group | Role | What they receive |
|---|---|---|
| andrological patients | shear wave elastosonography of the corpora cavernosa was performed to all patients who went to our clinic for andrological problems. in addition, the International Index of Erectile Function short form (IIEF5) questionnaire and the Erectile Hardness Score (EHS) questionnaire were administered. Receives: Diagnostic Test: shear Wave Elastosonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave elastosonografy and Erectile tissues Stiffness.
use of shear wave elastosonography for the diagnosis of erectile dysfunction by measuring the stiffness of the erectile tissue. the rigidity of the cavernous bodies is expressed in numerical values obtained in Kilopascals.
Measured: 15 days
Shear Wave Elastosonography and IIEF5 questionnaire
comparison between the score in the International index of Erectile Function short form questionnaire (minimum value is 5 and maximum value is 25) and the stiffness values obtained by elastosonography with numerical absolute values obtained in kilopascals
Measured: 15 days
Shear Wave elastosonography and EHS questionnaire
comparison between the score in the Erectile hardness Score questionnaire (minimum value is 0 an maximum value is 4) and the stiffness absolute values obtained by elastosonography with the numerical values obtained in kilopascals
Measured: 15 days
Secondary outcomes (1)
cut-off value at elastosonography and erectile dysfunction
The secondary objective aim of the our study is was to establish a cut-off value expressed in kilopascal to the elastosonographic Shear Wave Eelastosonography examination identifies the patient may develop erectile dysfunction due to cavernous tissue rigidity.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start13 May 2020
- Primary completion20 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabetta Costantini, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399057
- Sponsor's protocol ID
- EDSWE1
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT04399057
- Acronym / sponsor ID
- EDSWE1
- Conditions
- Erectile Dysfunction, Penile Diseases
- Keywords
- erectile dysfunction, elastosonography, penile diseases, International index of erectile function, erectile hardness score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 20 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 22 May 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.
the study proposes the use of a new non-invasive ultrasound method for the diagnosis of erectile dysfunction. in particular, the shear Wave elastosonosgraphy of the corpora cavernosa will be used. this last method quantitatively measures the rigidity of the analyzed tissues.
Detailed description
erectile function is a complex mechanism in which the elasticity of the tissues that make up the corpora cavernosa is fundamental. indeed, anatomopathological studies have shown that in patients with erectile dysfunction the elastic fibers are replaced by inextensible collagen. the aim of the study is the correlation between penile stiffness measured with this new non-invasive diagnostic method - elastosonography of the corpora cavernosa - and the correlation with validated questionnaires. the international Index of Erectile Function (IIEF5) short form and the erectile Hardness Score (EHS) will be used.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| andrological patients | – | Diagnostic Test: shear Wave Elastosonographyshear wave elastosonography of the corpora cavernosa was performed to all patients who went to our clinic for andrological problems. in addition, the International Index of Erectile Function short form (IIEF5) questionnaire and the Erectile Hardness Score (EHS) questionnaire were administered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- the population chosen is male, who goes to the clinics for andrological problems.
Key inclusion criteria (1 listed)
- male who came attended our general andrology clinic between January 2019 to January 2020.
Key exclusion criteria (9 listed)
- with: age >80 years or <18 years. , 2
- diabetes,
- spinal trauma,
- treatment with continuous PDE5i,
- ischemic heart disease for less than 6 months,
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 |
|---|---|---|
| shear Wave Elastosonographyboth the left cavernous body and the right cavernous body are ideally divided longitudinally into three sections: proximal, middle and distal. subsequently for each section of the corpora cavernosa the stiffness of the tissue is calculated by means of a specific Region Of Interest (ROI). the result is expressed in Kilopascals and in a color scale. when registering the stiffness the patient is asked to hold their breath. | Diagnostic test | andrological patients |
Primary outcome
Shear Wave elastosonografy and Erectile tissues Stiffness.
Time frame: 15 days
use of shear wave elastosonography for the diagnosis of erectile dysfunction by measuring the stiffness of the erectile tissue. the rigidity of the cavernous bodies is expressed in numerical values obtained in Kilopascals.
Shear Wave Elastosonography and IIEF5 questionnaire
Time frame: 15 days
comparison between the score in the International index of Erectile Function short form questionnaire (minimum value is 5 and maximum value is 25) and the stiffness values obtained by elastosonography with numerical absolute values obtained in kilopascals
Shear Wave elastosonography and EHS questionnaire
Time frame: 15 days
comparison between the score in the Erectile hardness Score questionnaire (minimum value is 0 an maximum value is 4) and the stiffness absolute values obtained by elastosonography with the numerical values obtained in kilopascals
1 secondary outcome
cut-off value at elastosonography and erectile dysfunction
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- 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.
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 and Penile Diseases, run by University Of Perugia 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 1 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: status not confirmed, as of the sponsor's last update on 22 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave elastosonografy and Erectile tissues Stiffness. (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2020.