Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction

Sponsor
University Of Perugia (Other)
Overall Status
Unknown status
CT.gov ID
NCT04399057
Collaborator
(none)
322
1
18
544.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: shear Wave Elastosonography

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 Design

Study Type:
Observational
Anticipated Enrollment :
322 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.
Actual Study Start Date :
May 13, 2020
Anticipated Primary Completion Date :
May 20, 2020
Anticipated Study Completion Date :
May 31, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Male
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elisabetta Costantini Terni Italy 05100

Sponsors and Collaborators

  • University Of Perugia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elisabetta Costantini, Chief U.O.C. Chirurgia Urologica ad indirizzo andrologico ed Uroginecologico, University Of Perugia
ClinicalTrials.gov Identifier:
NCT04399057
Other Study ID Numbers:
  • EDSWE1
First Posted:
May 22, 2020
Last Update Posted:
May 22, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Keywords provided by Elisabetta Costantini, Chief U.O.C. Chirurgia Urologica ad indirizzo andrologico ed Uroginecologico, University Of Perugia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2020