Re-operativeNCT07424768
Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty
An observational study of Re-operative and Hypospadias, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the outcomes, feasibility, and complication profile of re-operative hypospadias repair using tubularized incised plate urethroplasty as a single-stage procedure in a single-center experience. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Re-operative, Hypospadias, Tubularized Incised Plate
- What is being tested?
- Tubularized Incised Plate Urethroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2025
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: We will conduct a retrospective review of 15 pediatric cases who presented or referred with complications requiring reoperation after primary hypospadias repair, including urethrocutaneous fistula, meatal stenosis, or poor urinary stream. This study will be conducted at Tanta university hospitals from January 2021 to december 2025. The data will be collected from 1st January 2026 to 1st February 2026.
Who may be able to join
- Both sexes.
- Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse, defined as a plate width of at least 8-9 mm with acceptable vascularity and without severe fibrosis.
Who cannot join
- Patients with severely scared or fibrotic urethral plates are not suitable for tubularization.
- Absent or destroyed urethral plates following previous failed hypospadias repairs.
- Patients require staged urethral reconstruction rather than a single-stage procedure.
- Presence of poor urethral plate vascularity or ischemic tissue.
- Extensive penile scarring or fibrosis resulting from multiple previous surgical attempts.
- Severe penile curvature requiring excision of the urethral plate.
- Inability to achieve adequate, well-vascularized tissue coverage over the neourethra.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the outcomes, feasibility, and complication profile of re-operative hypospadias repair using tubularized incised plate urethroplasty as a single-stage procedure in a single-center experience.
Read the detailed description
Hypospadias repair remains one of the most common reconstructive procedures in pediatric urology; however, re-operative hypospadias represents a challenging subset due to distorted anatomy, urethral plate scarring, deficient local tissues, and higher complication rates compared with primary repairs.
The tubularized incised plate (TIP) urethroplasty, originally described by Snodgrass, revolutionized primary hypospadias repair and has since been adapted for selected reoperative cases. Contemporary evidence suggests that despite prior surgery and scary, a well-vascularized urethral plate of adequate width can still be successfully tubularized following a midline relaxing incision, offering acceptable functional and cosmetic outcomes.
- Conditions
- Re-operative, Hypospadias, Tubularized Incised Plate, Urethroplasty
- Being tested
- Tubularized Incised Plate Urethroplasty
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubularized Incised Plate UrethroplastyProcedure or surgery
All procedures were performed under general anesthesia using the tubularized incised plate technique. After completing penile degloving and exposure of the urethral plate, a midline longitudinal incision was made along the entire length of the plate to allow tension-free tubularization. The urethral plate was then tubularized over an appropriate-sized urethral catheter using fine absorbable sutures. A well-vascularized dartos flap was harvested and interposed as a protective layer over the neourethra, followed by meticulous skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse. Receives: Procedure: Tubularized Incised Plate Urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The success rate of tubularized incised plate urethroplasty reoperation after treatment was recorded.
Measured: 6 months after the procedure
Secondary outcomes (3)
Incidence of complications
Incidence of postoperative complications such as fistula, meatal stenosis, glans dehiscence, and urethral stricture were recorded.
Measured: 6 months after the procedure
Incidence of postoperative urethrocutaneous fistula
Incidence of postoperative urethrocutaneous fistula was recorded.
Measured: 6 months after the procedure
Incidence of meatal stenosis
Incidence of meatal stenosis was recorded.
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2021
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-operativeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Mohamed Salama, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424768
- Sponsor's protocol ID
- 36264PR1310136/1/26
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty
- ClinicalTrials.gov ID
- NCT07424768
- Acronym / sponsor ID
- 36264PR1310136/1/26
- Conditions
- Re-operative, Hypospadias, Tubularized Incised Plate, Urethroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 Feb 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.
The aim of this study is to evaluate the outcomes, feasibility, and complication profile of re-operative hypospadias repair using tubularized incised plate urethroplasty as a single-stage procedure in a single-center experience.
Detailed description
Hypospadias repair remains one of the most common reconstructive procedures in pediatric urology; however, re-operative hypospadias represents a challenging subset due to distorted anatomy, urethral plate scarring, deficient local tissues, and higher complication rates compared with primary repairs.
The tubularized incised plate (TIP) urethroplasty, originally described by Snodgrass, revolutionized primary hypospadias repair and has since been adapted for selected reoperative cases. Contemporary evidence suggests that despite prior surgery and scary, a well-vascularized urethral plate of adequate width can still be successfully tubularized following a midline relaxing incision, offering acceptable functional and cosmetic outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Tubularized Incised Plate UrethroplastyChildren with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We will conduct a retrospective review of 15 pediatric cases who presented or referred with complications requiring reoperation after primary hypospadias repair, including urethrocutaneous fistula, meatal stenosis, or poor urinary stream. This study will be conducted at Tanta university hospitals from January 2021 to december 2025. The data will be collected from 1st January 2026 to 1st February 2026.
Key inclusion criteria (2 listed)
- Both sexes.
- Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse, defined as a plate width of at least 8-9 mm with acceptable vascularity and without severe fibrosis.
Key exclusion criteria (7 listed)
- Patients with severely scared or fibrotic urethral plates are not suitable for tubularization.
- Absent or destroyed urethral plates following previous failed hypospadias repairs.
- Patients require staged urethral reconstruction rather than a single-stage procedure.
- Presence of poor urethral plate vascularity or ischemic tissue.
- Extensive penile scarring or fibrosis resulting from multiple previous surgical attempts.
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 |
|---|---|---|
| Tubularized Incised Plate UrethroplastyAll procedures were performed under general anesthesia using the tubularized incised plate technique. After completing penile degloving and exposure of the urethral plate, a midline longitudinal incision was made along the entire length of the plate to allow tension-free tubularization. The urethral plate was then tubularized over an appropriate-sized urethral catheter using fine absorbable sutures. A well-vascularized dartos flap was harvested and interposed as a protective layer over the neourethra, followed by meticulous skin closure. | Procedure or surgery | Study group |
Primary outcome
Success rate
Time frame: 6 months after the procedure
The success rate of tubularized incised plate urethroplasty reoperation after treatment was recorded.
3 secondary outcomes
Incidence of complications
Time frame: 6 months after the procedure
Incidence of postoperative urethrocutaneous fistula
Time frame: 6 months after the procedure
Incidence of meatal stenosis
Time frame: 6 months after the procedure
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 20 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Re-operative and Hypospadias, run by Tanta 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 2 inclusion and 7 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 20 Feb 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?
Success rate (time frame: 6 months after the procedure). 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 20 Feb 2026.