Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399057
• Other study ID #: EDSWE1
• Status: Recruiting
• Start date: May 13, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2020
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: May 31, 2020
• Est. primary completion date: May 20, 2020
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

male who came attended our general andrology clinic between January 2019 to January 2020.

Exclusion Criteria:

1. with: age >80 years or <18 years. , 2

2. diabetes,

3. spinal trauma,

4. treatment with continuous PDE5i,

5. ischemic heart disease for less than 6 months,

6. pelvic surgery for within less than 1 year,

7. hypotestosteronemia (<8 nmol/L),

8. La Peyronie's disease.

9. penile trauma.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Penile Diseases

Intervention

Diagnostic Test:
• shear Wave Elastosonography
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.

Locations

Country	Name	City	State
Italy	Elisabetta Costantini	Terni

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 days
Primary	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	15 days
Primary	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	15 days
Secondary	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.	15 days