Studying the Incidence of Erectile Dysfunction in Patients Complaining of Congenital Penile Curvature

January 12, 2022 updated by: Adham ZAAZAA, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adult males complaining of congenital penile curvature

Description

Inclusion Criteria:

  • Complaining of congenital curvature

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal erectile response
Peak systolic velocity above 35cm/s, EDV below 5cm/s, Erectile score 4 or 3
Diagnostic test: Penile Duplex Study
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
Abnormal erectile response
Peak systolic velocity below 35cm/s, EDV above 5cm/s, Erectile score 2 or 1
Diagnostic test: Penile Duplex Study
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years
Degree of curvature
Time Frame: 3 years
Angle and degree of penile curvature using a compass
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Adham ZAAZAA, MD PhD MRCS FECSM, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CongCurv&ED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Upon publishing

IPD Sharing Access Criteria

Data will become available upon reasonable request once the manuscript has been published

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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