AzTrials
AzTrials

Hypospadias Repair SurgeryNCT06705699

Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias

A study testing Urethral mobilisation and Mathieu in people with Hypospadias Repair Surgery, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 6 months to 7 years, men only
Conditions the study is for
Hypospadias Repair Surgery
What is being tested?
Urethral mobilisation and Mathieu
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
25 Nov 2024to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 7 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mohamed abdelhamid, specialist contact

00201004663936

mohamed.abdelhameed1@med.aun.edu.eg

mohamed ahmed, prof contact

00201062226639

osman@aun.edu.eg

About this study

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.

Read the 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.

Being tested
Urethral mobilisation, Mathieu
Keywords
mathieu, urethral, mobilisation, hypospadias
Medical subject headings
Hypospadias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urethral mobilisationProcedure or surgery

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

  • MathieuProcedure or surgery

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

Study groups in NCT06705699
Study groupRoleWhat they receive
Urethral Mobilization TechniqueExperimental• Description: Involves mobilizing the urethral tube proximally and advancing it distally to the glans. The urethra is repositioned and sutured at the neomeatal position.
Receives: Procedure: Urethral mobilisation
Mathieu TechniqueExperimental• Description: Utilizes a perimeatal-based flap, which is flipped up to create the neourethra.
Receives: Procedure: Mathieu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. urethrocutaneous fistula

    Absence of urethrocutaneous fistula formation

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

    Measured: 1 month

  2. meatal stenosis

    absence of meatal stenosis

    Measured: 2 months

  3. wound infection

    absence of wound infection

    Measured: 1 week

  4. hematoma

    absence of hematoma

    Measured: 3 days

  5. neomeatus retraction

    absence of retraction of the neomeatus.

    Measured: 3 months

Secondary outcomes (4)
  1. quality of the urinary stream

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

    Measured: 2 months

  2. cosmetic

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

    Measured: 3 months

  3. shape

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

    Measured: 3 months

  4. position of the neomeatus

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start25 Nov 2024 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705699
Sponsor's protocol ID
Treatment of Hypospadias
Status last verified
Nov 2024
First submitted
20 Nov 2024
Last updated
26 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

A study testing Urethral mobilisation and Mathieu in people with Hypospadias Repair Surgery, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed abdelhamid, specialist (00201004663936, mohamed.abdelhameed1@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urethrocutaneous fistula (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in