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

To present update & experience in management of congenital penile curvature complex.

Study Overview

• Status: Completed
• Conditions: Congenital Anomaly; Chordee; Curvature of Penis; Torsion of the Penis
• Intervention / Treatment: Procedure: Modified Nesbit's procedure and dorsal dartos flap

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: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 34517
    • Mohamed M Shahin

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Clockwise rotation	Clockwise rotation of the penis (number & percent)	5 years
Counterlockwise rotation	Counterlockwise rotation of the penis (number & percent)	5 years
Ventral Curvature	Ventral Curvature of the penis (number & percent)	5 years
Dorsal Curvature	Dorsal Curvature of the penis (number & percent)	5 years
Lateral Curvature	Lateral Curvature of the penis (number & percent)	5 years
Age	Age of the patients (years)	5 years
Operative time	Operative time (minutes)	1 day (day of surgery)
Post-operative hospital stay	Hospital stay period (days)	1 week
Post-operative follow-up period	Follow-up period (months)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional impairment	Functional impairment (number & percent)	5 years
Aesthetic impairment	Aesthetic impairment (number & percent)	5 years
Residual curvature > 10°	Residual curvature > 10° (number & percent)	5 years
Residual rotation > 10°	Residual rotation > 10° (number & percent)	5 years
Post-operative paresthesia	Post-operative paresthesia (number & percent)	5 years
Skin ischemia	Skin ischemia (number & percent)	5 years
Hematoma	Hematoma (number & percent)	5 years
Dressing soaked with blood	Dressing soaked with blood (number & percent)	5 years

Collaborators and Investigators

• Sponsor: dr. Muhammad Abdelhafez Mahmoud, MD
• Investigators: Principal Investigator: Mohamed M Shahin, MD,PhD, Al-Azhar New Damietta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Congenital penile curvature;; Penile rotation;; Dorsal dartos flap;; Complex anomaly
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID 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