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

NCT04864288 | Completed DMC

• 1 other identifier: MS-182-2019
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Penile elastography measurement data

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

  4 months

Study Arms (2)

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

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

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS: lead
• Cairo University: collaborator

Study Sites (1)

Kasr Alainy outpatient clinics

Cairo, 11562, Egypt

Location

Related Publications (3)

• 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.

  PMID: 31617065 BACKGROUND

• 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.

  PMID: 16291031 RESULT

• 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.

  PMID: 28787549 RESULT

Study Officials

• Ramzy RM Elnabarawy

  Kasr Alainy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ramzy Elnabarawy

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 28, 2021
• Study Start: September 28, 2019
• Primary Completion: January 28, 2020
• Study Completion: April 30, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

EG (1)