NCT04399057|Unknown
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.
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a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.
Sponsor study identifier
observational
322
1 country
1
Study Start
May 13, 2020
Actual (reported)Primary Completion
May 20, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2020
Actual (reported)May 13, 2020
Actual (reported)May 20, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 22, 2020
Actual (reported)May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
cut-off value at elastosonography and erectile dysfunction
15 days
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
the population chosen is male, who goes to the clinics for andrological problems.
Elisabetta Costantini
Terni, 05100, Italy
First Submitted
May 12, 2020
First Posted
May 22, 2020
Study Start
May 13, 2020
Actual (reported)Primary Completion
May 20, 2020
Estimated (date passed)Endovascular Therapy for Erectile Dysfunction
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 22, 2020
Record last verified: 2020-05
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