Value of Penile Elastography in Diagnosis of Patients With Erectile Dysfunction and Non-responders to Intra-corporal Injection

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-28

Study Completion Date

2020-04-30

Brief Summary

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Penile erection is a neurovascular response that induces penile arterial dilatation, increased blood flow, and cavernous smooth muscles (CSM) relaxation; the enlarging corpora cavernosa compress the subtunical veins, against a rigid tunica albuginea, and entrap blood within the penis. Impaired CSM function can result in corporo veno-occlusive dysfunction (CVOD) and erectile dysfunction. Nevertheless, diagnostic tests, which can evaluate the status of CSM, are not clinically applicable. Penile elastography is a new promising tool that can assess the stiffness of the corpora cavernosa. Accordingly penile elastography can assess the status of the cavernous tissue and can distinguish patient with corporal fibrosis.

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Detailed Description

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Conditions

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To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

male patients (age ≥ 21) with erectile dysfunction (ED) and non-responders to intracorporal injection

Shear Wave Elastography

Intervention Type DEVICE

is a quantitative method in which the probe generates acoustic impulses through the tissue to create molecular vibration. These vibrations create shear waves so that elasticity might be calculated, because it is proportional to the speed of the waves

2

age matched thirty men with normal erectile function

Shear Wave Elastography

Intervention Type DEVICE

is a quantitative method in which the probe generates acoustic impulses through the tissue to create molecular vibration. These vibrations create shear waves so that elasticity might be calculated, because it is proportional to the speed of the waves

Interventions

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Shear Wave Elastography

is a quantitative method in which the probe generates acoustic impulses through the tissue to create molecular vibration. These vibrations create shear waves so that elasticity might be calculated, because it is proportional to the speed of the waves

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* For group 1: Patients (age ≥ 21) have established sexual relationship for at least 3 months. These patients are complaining of ED and not responding to intracorporal injections (ICI).
* For group 2: Men (age ≥ 21) have an established sexual relationship for at least 3 months. These men have normal erectile function.

Exclusion Criteria

* Peyronnie's disease, post-priapism corporal fibrosis, and clinically detected post traumatic corporal fibrosis, previous ICI therapy, history of penile and/or urethral surgery, liver cell failure, renal failure, heart failure, endocrinal diseases (e.g. thyroid- Adrenal), medications that may cause ED, and neurologic and psychotic disorders.

Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes