Erectile Dysfunction, Penile Diseases
Conditions
Keywords
erectile dysfunction, elastosonography, penile diseases, International index of erectile function, erectile hardness score
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTshear 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.
Sponsors
University Of Perugia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shear Wave elastosonografy and Erectile tissues Stiffness. | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cut-off value at elastosonography and erectile dysfunction | 15 days | 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. |
Countries
Italy
Outcome results
None listed