Narrow Urethral Plate HypospadiasNCT07592026

Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics

A study testing Slit-like Adjusted Mathieu and onlay island flap in people with Narrow Urethral Plate Hypospadias, run by Al-Azhar University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose** To compare the Slit-like Adjusted Mathieu (SLAM) technique versus the inner transverse preputial onlay island flap for repair of anterior and mid-penile hypospadias with narrow urethral plate, evaluating complication rates, surgical outcomes, and cosmetic results. Read more about this study

Who is it for?: Ages 6 months to 12 years, men only
Conditions the study is for: Narrow Urethral Plate Hypospadias
What is being tested?: Slit-like Adjusted Mathieu and onlay island flap
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: 1 May 2020to 31 Oct 2025
Phase: Interventional
Are there results?: None posted in the registry

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 12 years
Men only
No healthy volunteers
Child

Who may be able to join

anterior or mid-penile hypospadias
shallow and narrow urethral plate measuring <6 mm,
without or with mild penile curvature <30° after degloving

Who cannot join

wide urethral plate suitable for Tubularized Incised Plate (TIP) urethroplasty,
other types of hypospadias (penoscrotal, scrotal, or perineal),
moderate or severe penile curvature (>30°)
recurrent cases

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicine for boys, Al-Azhar university
Cairo

Other trials in Egypt

About this study

Official title: Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics: A Randomized Controlled Study

Purpose** To compare the Slit-like Adjusted Mathieu (SLAM) technique versus the inner transverse preputial onlay island flap for repair of anterior and mid-penile hypospadias with narrow urethral plate, evaluating complication rates, surgical outcomes, and cosmetic results.
Methods** This prospective randomized controlled study included 80 patients with anterior and mid-penile hypospadias with a urethral plate <6 mm, conducted at Al-Azhar University Hospitals, Cairo, Egypt, from May 2020 to October 2025. Patients were randomly allocated to SLAM repair (Group A, n=40) or inner transverse preputial onlay island flap (Group B, n=40). Follow-up ranged from 24 to 48 months. Outcomes were assessed using the Hypospadias Objective Scoring Evaluation (HOSE) questionnaire.

Conditions: Narrow Urethral Plate Hypospadias
Being tested: Slit-like Adjusted Mathieu, onlay island flap
Keywords: Hypospadias, Slit-like Adjusted Mathieu, Onlay island flap, Urethroplasty, HOSE score
Medical subject headings: Hypospadias

What participants receive

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

Slit-like Adjusted MathieuProcedure or surgery
Slit-like Adjusted Mathieu
onlay island flapProcedure or surgery
inner transverse preputial onlay island flap

Study groups in NCT07592026
Study group	Role	What they receive
SLAM repair	Active comparator	Slit-like Adjusted Mathieu Receives: Procedure: Slit-like Adjusted Mathieu
onlay island flap	Active comparator	inner transverse preputial onlay island flap Receives: Procedure: onlay island flap

What is being measured

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

postoperative complications
Measured: Follow-up was performed at 1, 3, 12, and 24 months to assess complications

Secondary outcomes (1)

Hypospadias Objective Scoring Evaluation score
a validated 5-point system, ranging from 5 to 16
Measured: at 12 months

Timeline

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

1 May 202031 Oct 2025

First posted18 May 2026
Study start1 May 2020
Primary completion31 Oct 2025
Study completion31 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Narrow Urethral Plate HypospadiasStudies of the same condition, open and under way.
More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07592026
Sponsor's protocol ID: ped_Surg._102MedResearch._0102
Status last verified: May 2026
First submitted: 6 May 2026
Last updated: 18 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT07592026
Acronym / sponsor ID: ped_Surg._102MedResearch._0102
Conditions: Narrow Urethral Plate Hypospadias
Keywords: Hypospadias, Slit-like Adjusted Mathieu, Onlay island flap, Urethroplasty, HOSE score
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Al-Azhar UniversityUniversity, hospital or other
Study start: 1 May 2020 (actual)
Primary completion: 31 Oct 2025 (actual)
Study completion: 31 Oct 2025 (actual)
First posted: 18 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Purpose** To compare the Slit-like Adjusted Mathieu (SLAM) technique versus the inner transverse preputial onlay island flap for repair of anterior and mid-penile hypospadias with narrow urethral plate, evaluating complication rates, surgical outcomes, and cosmetic results.
Methods** This prospective randomized controlled study included 80 patients with anterior and mid-penile hypospadias with a urethral plate <6 mm, conducted at Al-Azhar University Hospitals, Cairo, Egypt, from May 2020 to October 2025. Patients were randomly allocated to SLAM repair (Group A, n=40) or inner transverse preputial onlay island flap (Group B, n=40). Follow-up ranged from 24 to 48 months. Outcomes were assessed using the Hypospadias Objective Scoring Evaluation (HOSE) questionnaire.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SLAM repair	Active comparator	Procedure: Slit-like Adjusted MathieuSlit-like Adjusted Mathieu
onlay island flap	Active comparator	Procedure: onlay island flapinner transverse preputial onlay island flap

Who may qualify

Ages: 6 months to 12 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

anterior or mid-penile hypospadias
shallow and narrow urethral plate measuring <6 mm,
without or with mild penile curvature <30° after degloving

Key exclusion criteria (4 listed)

wide urethral plate suitable for Tubularized Incised Plate (TIP) urethroplasty,
other types of hypospadias (penoscrotal, scrotal, or perineal),
moderate or severe penile curvature (>30°)
recurrent cases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Slit-like Adjusted MathieuSlit-like Adjusted Mathieu	Procedure or surgery	SLAM repair
onlay island flapinner transverse preputial onlay island flap	Procedure or surgery	onlay island flap

Primary outcome

postoperative complications
Time frame: Follow-up was performed at 1, 3, 12, and 24 months to assess complications

1 secondary outcome

Hypospadias Objective Scoring Evaluation score
Time frame: at 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Individual participant dataSharing planned: Yes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Slit-like Adjusted Mathieu and onlay island flap in people with Narrow Urethral Plate Hypospadias, run by Al-Azhar University at 1 site in Egypt.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative complications (time frame: Follow-up was performed at 1, 3, 12, and 24 months to assess complications). 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 NCT07592026.

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 18 May 2026.