Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias

NCT ID: NCT06705699

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2027-12-01

Brief Summary

The aim of this research is to compare the surgical outcomes of urethral mobilization and the Mathieu technique in treating distal penile hypospadias. The study will evaluate complication rates such as fistula formation and meatal stenosis, assess functional outcomes related to urinary stream quality, and analyze cosmetic results including the appearance of the neomeatus. Ultimately, the goal is to provide evidence-based guidance for choosing the most appropriate technique to optimize surgical outcomes and patient satisfaction.

Detailed Description

Hypospadias is a common congenital malformation of the male genitalia, characterized by the abnormal positioning of the urethral meatus along the ventral surface of the penis . It affects approximately 1 in every 200 male births and is most frequently observed in its distal form, where the urethral opening is located near the glans . Surgical correction of hypospadias is necessary to ensure proper urinary function, achieve a cosmetically acceptable appearance, and prevent future complications such as chordee or abnormal curvature of the penis . There are several surgical techniques available for repairing distal penile hypospadias, each with its own advantages and drawbacks. Among these, the Mathieu technique and the urethral mobilization technique are two commonly employed approaches.

The Mathieu technique, first introduced in 1932, uses a perimeatal-based flap to reconstruct the urethra. It is a reliable and well-established method that is associated with a relatively low rate of complications, such as urethrocutaneous fistula and meatal stenosis. However, one of the main limitations of the Mathieu technique is the creation of a rounded or horizontal meatus, which is often considered less cosmetically pleasing compared to the more natural slit-like meatus formed by other techniques. Despite this drawback, the Mathieu technique remains a popular choice for surgeons, particularly in cases where the urethral plate is well-developed and no additional ventral curvature correction is required.

The urethral mobilization technique, on the other hand, involves the proximal mobilization and distal advancement of the native urethra to the tip of the glans without using a preputial flap. This approach can be especially beneficial for boys who have already undergone circumcision, as it does not rely on the availability of a preputial skin flap. Studies suggest that urethral mobilization results in satisfactory functional outcomes and a lower incidence of certain complications, such as meatal stenosis and postoperative fistula formation. Furthermore, it is considered a straightforward procedure that avoids extensive tissue dissection, making it an appealing option for selected cases of distal hypospadias.

While both techniques have demonstrated satisfactory outcomes, there is a need for a comprehensive comparison to evaluate their effectiveness and safety profiles. Existing literature suggests that urethral mobilization results in lower complication rates compared to the Mathieu technique in specific clinical settings. Additionally, a study by reported that the Mathieu technique with an incision of the urethral plate showed significantly fewer complications, including meatal stenosis and fistula formation, compared to the tubularized incised-plate (TIP) technique, further demonstrating the variability in outcomes based on surgical approach.

Conditions

Hypospadias Repair Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Urethral Mobilization Technique

• Description: Involves mobilizing the urethral tube proximally and advancing it distally to the glans. The urethra is repositioned and sutured at the neomeatal position.

Group Type: EXPERIMENTAL

Urethral mobilisation

Intervention Type: PROCEDURE

Involves mobilizing the urethral tube proximally and advancing it distally to the glans. The urethra is repositioned and sutured at the neomeatal position.

Mathieu Technique

• Description: Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.

Group Type: EXPERIMENTAL

Mathieu

Intervention Type: PROCEDURE

Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.

Interventions

Urethral mobilisation

Involves mobilizing the urethral tube proximally and advancing it distally to the glans. The urethra is repositioned and sutured at the neomeatal position.

Intervention Type: PROCEDURE

Mathieu

Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with distal penile hypospadias (coronal, or subcoronal types).
• Mild to no chordee present (curvature <30°).
• No associated with severe genital anomalies.

Exclusion Criteria

• Patients with proximal hypospadias (midshaft, penoscrotal, or perineal).

• Presence of significant chordee requiring separate corrective procedures.
• Hypoplastic or poorly developed urethral plate that is unsuitable for surgical repair.
• Previous hypospadias repair surgery.
• Patients with severe comorbidities or conditions that could increase the risk of surgery (e.g., severe cardiac anomalies).

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elnoby Mohamed Abdelhameed

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ibrahim farag, prof

Role: STUDY_DIRECTOR

Assiut University

tarek hassan, prof

Role: STUDY_DIRECTOR

assuit

Central Contacts

Mohamed abdelhamid, specialist

Role: CONTACT

mohamed.abdelhameed1@med.aun.edu.eg

00201004663936

mohamed ahmed, prof

Role: CONTACT

osman@aun.edu.eg

00201062226639

References

Martínez ADCR, Barrientos-Villegas S, Mondragón CFM, Hernández EF, Martínez-Sosa IP, Mera BB, et al. Hypospadias: a review. International Surgery Journal. 2024;11(8):1439.

Reference Type: RESULT

Other Identifiers

Treatment of Hypospadias

Identifier Type: -

Identifier Source: org_study_id