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

Completed

• Conditions: To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC
• Interventions: Device: Shear Wave Elastography

• Registration Number: NCT04864288
• Lead Sponsor: Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-28
• Primary Completion: 2020-01-28
• Study Completion: 2020-04-30
• Status Verified: 2021-04
• Study First Submitted: 2021-04-24
• Study First Submitted QC: 2021-04-24
• Last Update Submitted: 2021-04-24
• Study First Posted: 2021-04-28
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Penile elastography measurement data	4 months	Measurements in kPa to detect quantity of elastic tissue compared to fibrous tissue

Trial Locations

Locations (1)

Kasr Alainy outpatient clinics; 🇪🇬 Cairo, Egypt