NCT06705699

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Dec 2027

First Submitted

Initial submission to the registry

November 20, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

November 20, 2024

Last Update Submit

November 22, 2024

Conditions

Hypospadias Repair Surgery

Keywords

mathieuurethralmobilisationhypospadias

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • quality of the urinary stream

    2 months

  • cosmetic

    3 months

  • shape

    3 months

  • position of the neomeatus

    3 months

Study Arms (2)

Urethral Mobilization Technique

EXPERIMENTAL

• 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

Mathieu Technique

EXPERIMENTAL

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

Procedure: Mathieu

Interventions

Urethral mobilisationPROCEDURE

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

Urethral Mobilization Technique
MathieuPROCEDURE

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

Mathieu Technique

Eligibility Criteria

Age6 Months - 7 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale children with hypospadias
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • ibrahim farag, prof

    Assiut University

    STUDY DIRECTOR

  • tarek hassan, prof

    assuit

    STUDY DIRECTOR

Central Study Contacts

Mohamed abdelhamid, specialist

CONTACT

00201004663936mohamed.abdelhameed1@med.aun.edu.eg

mohamed ahmed, prof

CONTACT

00201062226639osman@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
data analyst
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 26, 2024

Study Start

November 25, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share