Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction
a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.
1 other identifier
observational
322
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedMay 22, 2020
May 1, 2020
7 days
May 12, 2020
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
cut-off value at elastosonography and erectile dysfunction
15 days
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
the population chosen is male, who goes to the clinics for andrological problems.
You may qualify if:
- male who came attended our general andrology clinic between January 2019 to January 2020.
You may not qualify if:
- with: age \>80 years or \<18 years. , 2
- diabetes,
- spinal trauma,
- treatment with continuous PDE5i,
- ischemic heart disease for less than 6 months,
- pelvic surgery for within less than 1 year,
- hypotestosteronemia (\<8 nmol/L),
- La Peyronie's disease.
- penile trauma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elisabetta Costantini
Terni, 05100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief U.O.C. Chirurgia Urologica ad indirizzo andrologico ed Uroginecologico
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 22, 2020
Study Start
May 13, 2020
Primary Completion
May 20, 2020
Study Completion
May 31, 2020
Last Updated
May 22, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share