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OpenTrials
Completed

NCT Number: NCT04864288

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

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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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Kasr Alainy outpatient clinics

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shear Wave Elastography

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

Primary outcomes

  1. Penile elastography measurement data

    Time frame: 4 months

    Measurements in kPa to detect quantity of elastic tissue compared to fibrous tissue

Sponsors and collaborators

Lead sponsor

Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS

Other

Collaborators

  • Cairo University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2021
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.