Clinical trial NCT06705699: Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias
Official title: Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypospadias Repair Surgery
Keywords: mathieu
urethral
mobilisation
hypospadias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 60
Sex: MALE
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: urethrocutaneous fistula
timeFrame: 1 month
measure: meatal stenosis
timeFrame: 2 months
measure: wound infection
timeFrame: 1 week
measure: hematoma
timeFrame: 3 days
measure: neomeatus retraction
timeFrame: 3 months
Secondary outcomes:
measure: quality of the urinary stream
timeFrame: 2 months
measure: cosmetic
timeFrame: 3 months
measure: shape
timeFrame: 3 months
measure: position of the neomeatus
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: ibrahim farag, prof
role: STUDY_DIRECTOR
affiliation: assuit
name: tarek hassan, prof
role: STUDY_DIRECTOR
References:
citation: 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.