Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty

NCT07424768 | Completed

• 1 other identifier: 36264PR1310136/1/26
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the outcomes, feasibility, and complication profile of re-operative hypospadias repair using tubularized incised plate urethroplasty as a single-stage procedure in a single-center experience.

Conditions

Re-operative; Hypospadias; Tubularized Incised Plate; Urethroplasty

Outcome Measures

Primary Outcomes (1)

• Success rate

  The success rate of tubularized incised plate urethroplasty reoperation after treatment was recorded.

  6 months after the procedure

Secondary Outcomes (3)

• Incidence of complications

  6 months after the procedure

• Incidence of postoperative urethrocutaneous fistula

  6 months after the procedure

• Incidence of meatal stenosis

  6 months after the procedure

Study Arms (1)

Study group

Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse.

Procedure: Tubularized Incised Plate Urethroplasty

Interventions

Tubularized Incised Plate Urethroplasty PROCEDURE

All procedures were performed under general anesthesia using the tubularized incised plate technique. After completing penile degloving and exposure of the urethral plate, a midline longitudinal incision was made along the entire length of the plate to allow tension-free tubularization. The urethral plate was then tubularized over an appropriate-sized urethral catheter using fine absorbable sutures. A well-vascularized dartos flap was harvested and interposed as a protective layer over the neourethra, followed by meticulous skin closure.

Study group

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We will conduct a retrospective review of 15 pediatric cases who presented or referred with complications requiring reoperation after primary hypospadias repair, including urethrocutaneous fistula, meatal stenosis, or poor urinary stream. This study will be conducted at Tanta university hospitals from January 2021 to december 2025. The data will be collected from 1st January 2026 to 1st February 2026.

You may qualify if:

• Both sexes.
• Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse, defined as a plate width of at least 8-9 mm with acceptable vascularity and without severe fibrosis.

You may not qualify if:

• Patients with severely scared or fibrotic urethral plates are not suitable for tubularization.
• Absent or destroyed urethral plates following previous failed hypospadias repairs.
• Patients require staged urethral reconstruction rather than a single-stage procedure.
• Presence of poor urethral plate vascularity or ischemic tissue.
• Extensive penile scarring or fibrosis resulting from multiple previous surgical attempts.
• Severe penile curvature requiring excision of the urethral plate.
• Inability to achieve adequate, well-vascularized tissue coverage over the neourethra.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Surgery, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: January 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)