Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction

• Conditions: Erectile Dysfunction; Penile Diseases
• Interventions: Diagnostic Test: shear Wave Elastosonography

• Registration Number: NCT04399057
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study Start: 2020-05-13
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Primary Completion: 2020-05-20
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 322

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
andrological patients	shear Wave Elastosonography	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Elisabetta Costantini; 🇮🇹 Terni, Italy