Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction

NCT ID: NCT04399057

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-13

Study Completion Date

2020-05-31

Brief Summary

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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

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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

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Erectile Dysfunction Penile Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

shear Wave Elastosonography

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Of Perugia

OTHER

Sponsor Role lead

Responsible Party

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Elisabetta Costantini

Chief U.O.C. Chirurgia Urologica ad indirizzo andrologico ed Uroginecologico

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Elisabetta Costantini

Terni, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Elisabetta Costantini, Professor

Role: primary

3283620614

Ester Illiano, MD

Role: backup

3283620614

Other Identifiers

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EDSWE1

Identifier Type: -

Identifier Source: org_study_id

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