HypospadiasNCT03911635
Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias
A study testing URAGPI technique in people with Hypospadias, run by Assiut University.
Trial summary
Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis. Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- URAGPI technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Mar 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 1 year to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al
Who cannot join
- circumcised patients
- sever degrees of chordae
- previous surgical repair
- meatal stenosis
About this study
Official title: Applying of Urethral Advancement, Glanuloplasty and Preputioplasty Technique for More Proximal Degrees of Hypospadias. Selective Criteria and a Modified Technique
Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis.
Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations [1]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias [2]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty \" URAGPI\" versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion.
- Normal appearance of the penis. C) Good functional results.
- Conditions
- Hypospadias
- Being tested
- URAGPI technique
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URAGPI techniqueProcedure or surgery
the Urethral Advancement, Glanuloplasty and Preputioplasty
| Study group | Role | What they receive |
|---|---|---|
| Hypospadias in children | Experimental | Distal shaft hypospadias at age of 12 years or less Receives: Procedure: URAGPI technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks
evaluation according to "Hypospadias Objective Penile Evaluation Score"
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Apr 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911635
- Sponsor's protocol ID
- URAGPI in hypospadias
- Status last verified
- Jan 2020
- First submitted
- 23 Mar 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying of Urethral Advancement, Glanuloplasty and Preputioplasty Technique for More Proximal Degrees of Hypospadias. Selective Criteria and a Modified Technique
- ClinicalTrials.gov ID
- NCT03911635
- Acronym / sponsor ID
- URAGPI in hypospadias
- Conditions
- Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 11 Apr 2019 (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.
Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis.
Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations [1]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias [2]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty \" URAGPI\" versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion.
- Normal appearance of the penis. C) Good functional results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypospadias in children | Experimental | Procedure: URAGPI techniqueDistal shaft hypospadias at age of 12 years or less |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al
Key exclusion criteria (4 listed)
- circumcised patients
- sever degrees of chordae
- previous surgical repair
- meatal stenosis
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 |
|---|---|---|
| URAGPI techniquethe Urethral Advancement, Glanuloplasty and Preputioplasty | Procedure or surgery | Hypospadias in children |
Primary outcome
Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks
Time frame: 3 weeks
evaluation according to "Hypospadias Objective Penile Evaluation Score"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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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 URAGPI technique in people with Hypospadias, 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 1 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: status not confirmed, as of the sponsor's last update on 9 Jan 2020. 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?
Results are not available in the source record.
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?
Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks (time frame: 3 weeks). 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 9 Jan 2020.