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.
NCT number | NCT04399057 |
Other study ID # | EDSWE1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 13, 2020 |
Est. completion date | May 31, 2020 |
Verified date | May 2020 |
Source | University Of Perugia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 322 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 20, 2020 |
Accepts healthy volunteers | |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Elisabetta Costantini | Terni |
Lead Sponsor | Collaborator |
---|---|
University Of Perugia |
Italy,
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 |
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