To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CCNCT04864288
Value of Penile Elastography in Diagnosis of Patients With Erectile Dysfunction and Non-responders to Intra-corporal Injection
An observational study of To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC, run by Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC
- What is being tested?
- Shear Wave Elastography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2019to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attendng Andrology clinic/ department and ultrasound unit at the radiology department at faculty of Medicine, Cairo University.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Shear Wave Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave ElastographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | male patients (age ≥ 21) with erectile dysfunction (ED) and non-responders to intracorporal injection Receives: Device: Shear Wave Elastography | |
| 2 | age matched thirty men with normal erectile function Receives: Device: Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile elastography measurement data
Measurements in kPa to detect quantity of elastic tissue compared to fibrous tissue
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start28 Sep 2019
- Primary completion28 Jan 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS, Cairo University
- Investigators
- Ramzy RM Elnabarawy, Principal investigator, Kasr Alainy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864288
- Sponsor's protocol ID
- MS-182-2019
- Status last verified
- Apr 2021
- First submitted
- 24 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be made available upon request.
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 31617065Dean 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 16291031Hamidi 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Penile Elastography in Diagnosis of Patients With Erectile Dysfunction and Non-responders to Intra-corporal Injection
- ClinicalTrials.gov ID
- NCT04864288
- Acronym / sponsor ID
- MS-182-2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCSUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 28 Sep 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Shear Wave Elastographymale patients (age ≥ 21) with erectile dysfunction (ED) and non-responders to intracorporal injection |
| 2 | – | Device: Shear Wave Elastographyage matched thirty men with normal erectile function |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attendng Andrology clinic/ department and ultrasound unit at the radiology department at faculty of Medicine, Cairo University.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave Elastographyis 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 | Device | 1, 2 |
Primary outcome
Penile elastography measurement data
Time frame: 4 months
Measurements in kPa to detect quantity of elastic tissue compared to fibrous tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 31617065Hassanin 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.
- Results publication: PubMed 16291031Dean 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.
- Results publication: PubMed 28787549Hamidi 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.
- Individual participant dataSharing planned: Undecided. To be made available upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramzy RM Elnabarawy principal investigator
Kasr Alainy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC, run by Ramzy Raafat Mohamed Mohamed Elnabarawy, MD, MSc, MRCS at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile elastography measurement data (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864288, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.