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CompletedNCT04864288Updated Apr 28, 2021

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

An observational study in To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC, sponsored by Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS. Completed at 1 site in Egypt. Open to male participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
21 Years and older
Sex
Male
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Study summary

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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Conditions studied

  • To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC
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In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 80 is below the median of 130 across 115 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

This is the only study on the registry with Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients attendng Andrology clinic/ department and ultrasound unit at the radiology department at faculty of Medicine, Cairo University.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

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

    Device: Shear Wave Elastography

  • 2

    age matched thirty men with normal erectile function

    Device: Shear Wave Elastography

Interventions

  • DeviceShear 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

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What researchers measure

Primary outcomes

  1. Penile elastography measurement data

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

    Time frame: 4 months

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Study locations

1 site
  • Kasr Alainy outpatient clinics
    Cairo, 11562, Egypt
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References and documents

Publications

  • Hassanin AM, Abdel-Hamid AZ. Cavernous smooth muscles: innovative potential therapies are promising for an unrevealed clinical diagnosis. Int Urol Nephrol. 2020 Feb;52(2):205-217. doi: 10.1007/s11255-019-02309-9. Epub 2019 Oct 15. PubMed 31617065 ↗
  • Dean RC, Lue TF. Physiology of penile erection and pathophysiology of erectile dysfunction. Urol Clin North Am. 2005 Nov;32(4):379-95, v. doi: 10.1016/j.ucl.2005.08.007. PubMed 16291031 ↗
  • Hamidi N, Altinbas NK, Gokce MI, Suer E, Yagci C, Baltaci S, Turkolmez K. Preliminary results of a new tool to evaluate cavernous body fibrosis following radical prostatectomy: penile elastography. Andrology. 2017 Sep;5(5):999-1006. doi: 10.1111/andr.12408. Epub 2017 Aug 8. PubMed 28787549 ↗

Individual participant data

Plan to share: Undecided — To be made available upon request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04864288
Lead sponsor
Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS
Collaborators
Cairo University
Responsible party
Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS (Ramzy Elnabarawy, Cairo University) — Sponsor-investigator
First posted
Apr 28, 2021
Start date
Sep 28, 2019
Primary completion
Jan 28, 2020
Completion
Apr 30, 2020
Last update
Apr 28, 2021

Study contacts

Ramzy RM Elnabarawy
principal investigator · Kasr Alainy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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