Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06705699

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Urethral mobilisation

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

Procedure

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

Primary outcomes

  1. urethrocutaneous fistula

    Time frame: 1 month

    Absence of urethrocutaneous fistula formation

    • Postoperative complication rates, including urethrocutaneous fistula formation, meatal stenosis, wound infection, hematoma, and retraction of the neomeatus.
  2. meatal stenosis

    Time frame: 2 months

    absence of meatal stenosis

  3. wound infection

    Time frame: 1 week

    absence of wound infection

  4. hematoma

    Time frame: 3 days

    absence of hematoma

  5. neomeatus retraction

    Time frame: 3 months

    absence of retraction of the neomeatus.

Secondary outcomes

  1. quality of the urinary stream

    Time frame: 2 months

    Functional outcomes assessed by the quality of the urinary stream (single stream, narrow stream, sprayed stream).

  2. cosmetic

    Time frame: 3 months

    Cosmetic outcomes evaluated using the HOSE scoring system to assess the appearance.

  3. shape

    Time frame: 3 months

    Cosmetic outcomes evaluated using the HOSE scoring system to assess the shape.

  4. position of the neomeatus

    Time frame: 3 months

    Cosmetic outcomes evaluated using the HOSE scoring system to assess the position of the neomeatus.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed abdelhamid, specialist

CONTACT

[email protected]

00201004663936

mohamed ahmed, prof

CONTACT

[email protected]

00201062226639

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.