Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypospadias Repair Surgery
• Intervention / Treatment: Procedure: Urethral mobilisation; Procedure: Mathieu

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed abdelhamid, specialist; Phone Number: 00201004663936; Email: mohamed.abdelhameed1@med.aun.edu.eg
• Study Contact Backup: Name: mohamed ahmed, prof; Phone Number: 00201062226639; Email: osman@aun.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:• Male patients aged 6 months to 7 years.

• 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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: Mathieu Technique; • Description: Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.	Procedure: Mathieu; Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urethrocutaneous fistula	Absence of urethrocutaneous fistula formation • Postoperative complication rates, including urethrocutaneous fistula formation, meatal stenosis, wound infection, hematoma, and retraction of the neomeatus.	1 month
meatal stenosis	absence of meatal stenosis	2 months
wound infection	absence of wound infection	1 week
hematoma	absence of hematoma	3 days
neomeatus retraction	absence of retraction of the neomeatus.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of the urinary stream	Functional outcomes assessed by the quality of the urinary stream (single stream, narrow stream, sprayed stream).	2 months
cosmetic	Cosmetic outcomes evaluated using the HOSE scoring system to assess the appearance.	3 months
shape	Cosmetic outcomes evaluated using the HOSE scoring system to assess the shape.	3 months
position of the neomeatus	Cosmetic outcomes evaluated using the HOSE scoring system to assess the position of the neomeatus.	3 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: ibrahim farag, prof, Assiut University; Study Director: tarek hassan, prof, Assuit

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hypospadias; mobilisation; urethral; mathieu
• 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; Hypospadias
• Other Study ID Numbers: Treatment of Hypospadias

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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