Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics

Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics: A Randomized Controlled Study

• Purpose** To compare the Slit-like Adjusted Mathieu (SLAM) technique versus the inner transverse preputial onlay island flap for repair of anterior and mid-penile hypospadias with narrow urethral plate, evaluating complication rates, surgical outcomes, and cosmetic results.
• Methods** This prospective randomized controlled study included 80 patients with anterior and mid-penile hypospadias with a urethral plate <6 mm, conducted at Al-Azhar University Hospitals, Cairo, Egypt, from May 2020 to October 2025. Patients were randomly allocated to SLAM repair (Group A, n=40) or inner transverse preputial onlay island flap (Group B, n=40). Follow-up ranged from 24 to 48 months. Outcomes were assessed using the Hypospadias Objective Scoring Evaluation (HOSE) questionnaire.

Study Overview

• Status: Completed
• Conditions: Narrow Urethral Plate Hypospadias
• Intervention / Treatment: Procedure: Slit-like Adjusted Mathieu; Procedure: onlay island flap

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of medicine for boys, Al-Azhar university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• anterior or mid-penile hypospadias
• shallow and narrow urethral plate measuring <6 mm,
• without or with mild penile curvature <30° after degloving

Exclusion Criteria:

• wide urethral plate suitable for Tubularized Incised Plate (TIP) urethroplasty,
• other types of hypospadias (penoscrotal, scrotal, or perineal),
• moderate or severe penile curvature (>30°)
• recurrent cases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SLAM repair; Slit-like Adjusted Mathieu	Procedure: Slit-like Adjusted Mathieu; Slit-like Adjusted Mathieu
Active Comparator: onlay island flap; inner transverse preputial onlay island flap	Procedure: onlay island flap; inner transverse preputial onlay island flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative complications	Follow-up was performed at 1, 3, 12, and 24 months to assess complications

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypospadias Objective Scoring Evaluation score	a validated 5-point system, ranging from 5 to 16	at 12 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypospadias; Urethroplasty; Slit-like Adjusted Mathieu; Onlay island flap; HOSE score
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Urogenital Abnormalities; Penile Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypospadias
• Other Study ID Numbers: ped_Surg._102MedResearch._0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No