Distal Penile Hypospadias (Disorder)NCT04946058
Hybrid Mathieu Urethroplasty
A study testing hyebrid Mathieu Urethroplasty in people with Distal Penile Hypospadias (Disorder), run by Tanta University.
Trial summary
the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure. Read more about this study
- Who is it for?
- Ages 6 months to 4 years, men only
- Conditions the study is for
- Distal Penile Hypospadias (Disorder)
- What is being tested?
- hyebrid Mathieu Urethroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2012to 15 Jan 2021
- 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 4 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- distal penile hypospadias
Who cannot join
- sever hypospadias
- cases need redo
About this study
the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.
Read the detailed description
background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty.
Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.
- Conditions
- Distal Penile Hypospadias (Disorder)
- Being tested
- hyebrid Mathieu Urethroplasty
- Keywords
- distal hypospadias, Mathieu urethroplasty, modified, urethral plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyebrid Mathieu UrethroplastyProcedure or surgery
incision of the urethral plate during the procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
successful treatment of distal penile hypospadias
use of HOSE as a measure o success o repair
Measured: 6 moths post operative
increase the scope of classic Mathieu urethroplasty
cases with glanular width from 10 mm to 15 mm were included
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start31 Mar 2012
- Primary completion31 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Penile Hypospadias (Disorder)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946058
- Sponsor's protocol ID
- 34403//1/21
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publishing an article including the operative details and results
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Mathieu Urethroplasty
- ClinicalTrials.gov ID
- NCT04946058
- Acronym / sponsor ID
- 34403//1/21
- Conditions
- Distal Penile Hypospadias (Disorder)
- Keywords
- distal hypospadias, Mathieu urethroplasty, modified, urethral plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 31 Mar 2012 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 30 Jun 2021 (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.
the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.
Detailed description
background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty.
Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- distal penile hypospadias
Key exclusion criteria (2 listed)
- sever hypospadias
- cases need redo
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 |
|---|---|---|
| hyebrid Mathieu Urethroplastyincision of the urethral plate during the procedure | Procedure or surgery | – |
Primary outcome
successful treatment of distal penile hypospadias
Time frame: 6 moths post operative
use of HOSE as a measure o success o repair
increase the scope of classic Mathieu urethroplasty
Time frame: 6 months post operative
cases with glanular width from 10 mm to 15 mm were included
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 30 Jun 2021.
- Individual participant dataSharing planned: Undecided. publishing an article including the operative details and results
Related trials for Distal Penile Hypospadias (Disorder)
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Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
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Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
Distal Hypospadias, Hypospadias
Enrolling by invitation
A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature
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Not yet recruiting
Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair
Penile Hypospadias
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Urethral Mobilisation Versus Mathieu Technique for Repair of Distal Hypospadias
Hypospadias Repair Surgery
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.
Questions about this trial
What is this clinical trial studying?
A study testing hyebrid Mathieu Urethroplasty in people with Distal Penile Hypospadias (Disorder), run by Tanta 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 1 inclusion and 2 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 30 Jun 2021. 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?
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?
successful treatment of distal penile hypospadias (time frame: 6 moths post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2021.