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

R

Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS

Status

Completed

Conditions

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

Treatments

Device: Shear Wave Elastography

Study type

Observational

Funder types

Other

Identifiers

NCT04864288
MS-182-2019

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Male

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

1
Description:
male patients (age ≥ 21) with erectile dysfunction (ED) and non-responders to intracorporal injection
Treatment:
Device: Shear Wave Elastography
2
Description:
age matched thirty men with normal erectile function
Treatment:
Device: Shear Wave Elastography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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