To Assess Erectile Function in Patients Complaining of Congenital Penile CurvatureNCT05191199
Studying the Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature
An observational study of To Assess Erectile Function in Patients Complaining of Congenital Penile Curvature, run by Cairo University at 1 site in Egypt.
Trial summary
Patients complaining of congenital penile curvature were subject to Penile duplex study to assess their curvature. Their penile duplex data including Peak Systolic velocity, End Diastolic velocity and Resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- To Assess Erectile Function in Patients Complaining of Congenital Penile Curvature
- What is being tested?
- Penile Duplex Study
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Dec 2021
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Adult males complaining of congenital penile curvature
Who may be able to join
- Complaining of congenital curvature
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature
Patients complaining of congenital penile curvature were subject to Penile duplex study to assess their curvature. Their penile duplex data including Peak Systolic velocity, End Diastolic velocity and Resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection using the erection hardness grading scale.
- Being tested
- Penile Duplex Study
- Keywords
- Congenital penile curvature, Erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile Duplex StudyDiagnostic test
A penile duplex study will be done to assess PSV, EDV, RI, angle and degree of curvature and Erection quality using the erection hardness grading scale
| Study group | Role | What they receive |
|---|---|---|
| Normal erectile response | Peak systolic velocity above 35cm/s, EDV below 5cm/s, Erectile score 4 or 3 Receives: Diagnostic Test: Penile Duplex Study | |
| Abnormal erectile response | Peak systolic velocity below 35cm/s, EDV above 5cm/s, Erectile score 2 or 1 Receives: Diagnostic Test: Penile Duplex Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile duplex study parameters
A penile duplex study will be done to assess peak systolic velocity, end diastolic velocity, Resistivity index
Measured: 3 years
Degree of curvature
Angle and degree of penile curvature using a compass
Measured: 3 years
Erection quality using the erection hardness grading scale
A score of 1 indicates that the penis is larger than normal, but not hard; 2 means the penis is hard, but not hard enough for penetration, 3 means the penis is hard enough for penetration but not completely hard, and 4 indicates that the penis is completely hard and fully rigid
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess Erectile Function in Patients Complaining of Congenital Penile CurvatureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham ZAAZAA, Cairo University
- Investigators
- Adham ZAAZAA, MD PhD MRCS FECSM, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191199
- Sponsor's protocol ID
- CongCurv&ED
- Status last verified
- Jan 2022
- First submitted
- 5 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature
- ClinicalTrials.gov ID
- NCT05191199
- Acronym / sponsor ID
- CongCurv&ED
- Keywords
- Congenital penile curvature, Erectile dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 13 Jan 2022 (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.
Patients complaining of congenital penile curvature were subject to Penile duplex study to assess their curvature. Their penile duplex data including Peak Systolic velocity, End Diastolic velocity and Resistivity index were recorded as well as their assessing the degree of curvature and the quality of their erection using the erection hardness grading scale.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal erectile response | – | Diagnostic Test: Penile Duplex StudyPeak systolic velocity above 35cm/s, EDV below 5cm/s, Erectile score 4 or 3 |
| Abnormal erectile response | – | Diagnostic Test: Penile Duplex StudyPeak systolic velocity below 35cm/s, EDV above 5cm/s, Erectile score 2 or 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult males complaining of congenital penile curvature
Key inclusion criteria (1 listed)
- Complaining of congenital curvature
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Penile Duplex StudyA penile duplex study will be done to assess PSV, EDV, RI, angle and degree of curvature and Erection quality using the erection hardness grading scale | Diagnostic test | Abnormal erectile response, Normal erectile response |
Primary outcome
Penile duplex study parameters
Time frame: 3 years
A penile duplex study will be done to assess peak systolic velocity, end diastolic velocity, Resistivity index
Degree of curvature
Time frame: 3 years
Angle and degree of penile curvature using a compass
Erection quality using the erection hardness grading scale
Time frame: 3 years
A score of 1 indicates that the penis is larger than normal, but not hard; 2 means the penis is hard, but not hard enough for penetration, 3 means the penis is hard enough for penetration but not completely hard, and 4 indicates that the penis is completely hard and fully rigid
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 13 Jan 2022.
- Individual participant dataSharing planned: Yes
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.
Adham ZAAZAA, MD PhD MRCS FECSM principal investigator
Cairo University
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 Assess Erectile Function in Patients Complaining of Congenital Penile Curvature, run by Cairo University 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 1 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 13 Jan 2022. 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 duplex study parameters (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2022.