One Stage Correction of Congenital Penile Curvature Complex (Al-AzharCPCC)

November 13, 2020 updated by: dr. Muhammad Abdelhafez Mahmoud, MD
To present update & experience in management of congenital penile curvature complex.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Type of study: prospective study

Review of literature:

  • Different modalities of urethroplasty for correction of CPCC without hypospadias (Nesbit, modified Nesbit, dorsal dartos flap, combined plication-incision CPI, suture fixation to pubic bone).
  • Merits of modified Nesbit technique accompanied by dorsal dartos flap for one-stage correction of CPCC without hypospadias.

This is a prospective study conducted at pediatric surgery department, New Damietta & Alhoussain Al-Azhar University Hospitals, from January 2015 to May 2020, on 56 male patients with isolated CPCC. All of them will undergo one-stage correction corporoplasty using modified Nesbit technique accompanied by dorsal dartos flap.

Institutes of the study:

A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals at New Damietta & Cairo. Number of cases: Fifty-six male patients. Time frame: period of 5.6 years.

Ethical Consideration:

The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The study protocol was approved by local research and ethics committee of Al-Azhar Faculty of Medicine; the study protocol was explained to all guardians and their informed consents were obtained for involvement in the study. Confidentiality and the right to withdraw from the study at any time were guaranteed.

Preoperative preparation:

Children with CPCC those fulfill inclusion criteria will undergo a nursing evaluation of functional health status and a preoperative evaluation by an anesthesiologist & pediatrician. The angle of penile rotation will be measured on the photograph, using Millen Med DICOM viewer program for image analysis, based on the orientation of the urethral meatus relative to the vertical position.

Follow-up:

Patients will be followed-up at OPD.

Statistical Analysis:

Data will be summarized into continuous variables expressed as mean ± standard deviation and categorical variables expressed as frequency count and percentage (%), using appropriate software computer package. Fisher's exact test is used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 is considered statistically significant.

Discussion:

It will focus on one-stage correction of congenital penile curvature complex (CPCC) using modified Nesbit's procedure (to correct curvature) and dorsal dartos flap (to correct torsion). The results obtained from this study will be compared between both group and with those reported in the literature. Also, it will focus on results, complications, their management, and clinical evaluation by noticing urine stream direction. At the end, the investigators will conclude that this technique ensures correction of the complex penile anomaly with satisfactory results and nice cosmetic outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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, 34517
        • Mohamed M Shahin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 2 to 10 years old boys
  • with congenital curvature complex of the penis
  • with normally situated urethral meatus.
  • The various degrees of penile curvature ranged between 30° - 90° associated with 30° - 90° penile rotation

Exclusion Criteria:

  • Boys with CPCC with abnormal urethral meatus as hypospadias or epispadias, or
  • with the range of angle degree of penile curvature less than 30° associated with less than 30° penile rotation or
  • with acquired penile curvature or
  • having an isolated lesion.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Modified Nesbit technique followed by dorsal dartos flap
Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion
Procedure: Modified Nesbit's procedure and dorsal dartos flap
Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clockwise rotation
Time Frame: 5 years
Clockwise rotation of the penis (number & percent)
5 years
Counterlockwise rotation
Time Frame: 5 years
Counterlockwise rotation of the penis (number & percent)
5 years
Ventral Curvature
Time Frame: 5 years
Ventral Curvature of the penis (number & percent)
5 years
Dorsal Curvature
Time Frame: 5 years
Dorsal Curvature of the penis (number & percent)
5 years
Lateral Curvature
Time Frame: 5 years
Lateral Curvature of the penis (number & percent)
5 years
Age
Time Frame: 5 years
Age of the patients (years)
5 years
Operative time
Time Frame: 1 day (day of surgery)
Operative time (minutes)
1 day (day of surgery)
Post-operative hospital stay
Time Frame: 1 week
Hospital stay period (days)
1 week
Post-operative follow-up period
Time Frame: 5 years
Follow-up period (months)
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional impairment
Time Frame: 5 years
Functional impairment (number & percent)
5 years
Aesthetic impairment
Time Frame: 5 years
Aesthetic impairment (number & percent)
5 years
Residual curvature > 10°
Time Frame: 5 years
Residual curvature > 10° (number & percent)
5 years
Residual rotation > 10°
Time Frame: 5 years
Residual rotation > 10° (number & percent)
5 years
Post-operative paresthesia
Time Frame: 5 years
Post-operative paresthesia (number & percent)
5 years
Skin ischemia
Time Frame: 5 years
Skin ischemia (number & percent)
5 years
Hematoma
Time Frame: 5 years
Hematoma (number & percent)
5 years
Dressing soaked with blood
Time Frame: 5 years
Dressing soaked with blood (number & percent)
5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
dr. Muhammad Abdelhafez Mahmoud, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed M Shahin, MD,PhD, Al-Azhar New Damietta 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Al-AzharCPCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature

IPD Sharing Time Frame

from now indefinitely

IPD Sharing Access Criteria

after the article became accepted and available online.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

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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