Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction

May 18, 2020 updated by: Elisabetta Costantini, University Of Perugia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Terni, Italy, 05100
        • Recruiting
        • Elisabetta Costantini
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ester Illiano, MD
        • Principal Investigator:
          • Elisabetta Costantini, Professor
        • Sub-Investigator:
          • Francesco Trama, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

the population chosen is male, who goes to the clinics for andrological problems.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shear Wave elastosonografy and Erectile tissues Stiffness.
Time Frame: 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.
15 days
Shear Wave Elastosonography and IIEF5 questionnaire
Time Frame: 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
15 days
Shear Wave elastosonography and EHS questionnaire
Time Frame: 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
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cut-off value at elastosonography and erectile dysfunction
Time Frame: 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.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Anticipated)

May 20, 2020

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDSWE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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