Distal Hypospadias RepairDPH repairNCT07832760
Topography Guided Repair Versus TIP for Distal Hypospadias
A study testing Topography Guided Repair and Tubularized Incised Plate Repair in people with Distal Hypospadias Repair, run by Alexandria University at 1 site in Egypt.
Trial summary
This study compares two surgical techniques used to repair distal hypospadias in children: topography-guided repair (TGR), a newer approach, and tubularized incised plate (TIP) repair, a commonly used standard technique. Children with distal hypospadias were randomly assigned to receive one of the two procedures. Read more about this study
- Who is it for?
- Ages 6 months to 16 years, men only
- Conditions the study is for
- Distal Hypospadias Repair
- What is being tested?
- Topography Guided Repair and Tubularized Incised Plate Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 8 Jun 2026
- 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 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children younger than 16 years with previously untreated distal penile hypospadias.
- Uncircumcised patients.
- Parent or caregiver able to provide written informed consent.
Who cannot join
- Previous hypospadias repair.
- Previous circumcision.
- Proximal hypospadias diagnosed before surgery.
- Penile curvature of 30 degrees or greater.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topography Guided Repair Versus Tubularized Incised Plate for Distal Hypospadias: A Randomized Pilot Trial of Early Adoption
This study compares two surgical techniques used to repair distal hypospadias in children: topography-guided repair (TGR), a newer approach, and tubularized incised plate (TIP) repair, a commonly used standard technique. Children with distal hypospadias were randomly assigned to receive one of the two procedures. Researchers assessed early surgical complications, need for additional surgery, and postoperative appearance and function during follow-up visits over 12 months. The study aims to determine whether TGR can be safely adopted by surgical teams other than its developer and to guide larger future studies.
- Conditions
- Distal Hypospadias Repair
- Being tested
- Topography Guided Repair, Tubularized Incised Plate Repair
- Keywords
- DPH, Topographic repair, TIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topography Guided RepairProcedure or surgery
Topography-guided repair is a surgical procedure for primary distal penile hypospadias. The repair involves identification and mobilization of the spongiosal pillars, excision of the ventral hypoplastic urothelial sheet, approximation of the spongiosal tissue over a silicone catheter, and subcuticular closure of the glanular wings. An 8-Fr silicone catheter is maintained for 7 days after surgery.
Tubularized Incised Plate RepairProcedure or surgery
Tubularized incised plate repair is a surgical procedure for primary distal penile hypospadias. The urethral plate is incised in the midline and tubularized to create a neourethra, followed by glans closure using 6-0 polyglactin sutures. An 8-Fr silicone catheter is maintained for 7 days after surgery. Postoperative dressing and wound-care protocols are the same as in the topography-guided repair group.
| Study group | Role | What they receive |
|---|---|---|
| Topography-Guided Repair (TGR) | Experimental | Distal Hypospadias Repair using the topographic anatomical repair technique Receives: Procedure: Topography Guided Repair |
| Tubularized Incised Plate Repair (TIP) | Active comparator | Distal Hypospadias Repair using the TiP technique Receives: Procedure: Tubularized Incised Plate Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication-Free Rate
The proportion of participants without postoperative complications, including urethrocutaneous fistula, meatal stenosis, glanular dehiscence, or other complications, at 3 months after the primary repair. Participants were classified according to their current complication status before any revision surgery.
Measured: 3 months after primary hypospadias repair
Secondary outcomes (2)
Complication-Free Rate at 12 Months
The proportion of participants without unresolved postoperative complications at 12 months after primary repair. Participants who had a complication that was successfully revised were classified as complication-free; participants with unresolved complications or pending revision were classified as complicated.
Measured: 12 months after primary hypospadias repair
Hypospadias Objective Scoring Evaluation (HOSE) Score
HOSE is an examiner-scored assessment of postoperative hypospadias repair outcome. Scores range from 5 to 16, with scores of 14 or higher considered an acceptable outcome.
Measured: 3 and 12 months after primary hypospadias repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Dec 2023
- Primary completion8 Sep 2025
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Hypospadias RepairStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Salama, Alexandria University
- Investigators
- Amr K. Salama, PhD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832760
- Sponsor's protocol ID
- 0108103
- Acronym
- DPH repair
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, including baseline characteristics, intraoperative measurements, complications, revision status, and outcome scores, may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topography Guided Repair Versus Tubularized Incised Plate for Distal Hypospadias: A Randomized Pilot Trial of Early Adoption
- ClinicalTrials.gov ID
- NCT07832760
- Acronym / sponsor ID
- DPH repair / 0108103
- Conditions
- Distal Hypospadias Repair
- Keywords
- DPH, Topographic repair, TIP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 22 Sep 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.
This study compares two surgical techniques used to repair distal hypospadias in children: topography-guided repair (TGR), a newer approach, and tubularized incised plate (TIP) repair, a commonly used standard technique. Children with distal hypospadias were randomly assigned to receive one of the two procedures. Researchers assessed early surgical complications, need for additional surgery, and postoperative appearance and function during follow-up visits over 12 months. The study aims to determine whether TGR can be safely adopted by surgical teams other than its developer and to guide larger future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topography-Guided Repair (TGR) | Experimental | Procedure: Topography Guided RepairDistal Hypospadias Repair using the topographic anatomical repair technique |
| Tubularized Incised Plate Repair (TIP) | Active comparator | Procedure: Tubularized Incised Plate RepairDistal Hypospadias Repair using the TiP technique |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children younger than 16 years with previously untreated distal penile hypospadias.
- Uncircumcised patients.
- Parent or caregiver able to provide written informed consent.
Key exclusion criteria (4 listed)
- Previous hypospadias repair.
- Previous circumcision.
- Proximal hypospadias diagnosed before surgery.
- Penile curvature of 30 degrees or greater.
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 |
|---|---|---|
| Topography Guided RepairTopography-guided repair is a surgical procedure for primary distal penile hypospadias. The repair involves identification and mobilization of the spongiosal pillars, excision of the ventral hypoplastic urothelial sheet, approximation of the spongiosal tissue over a silicone catheter, and subcuticular closure of the glanular wings. An 8-Fr silicone catheter is maintained for 7 days after surgery. | Procedure or surgery | Topography-Guided Repair (TGR) |
| Tubularized Incised Plate RepairTubularized incised plate repair is a surgical procedure for primary distal penile hypospadias. The urethral plate is incised in the midline and tubularized to create a neourethra, followed by glans closure using 6-0 polyglactin sutures. An 8-Fr silicone catheter is maintained for 7 days after surgery. Postoperative dressing and wound-care protocols are the same as in the topography-guided repair group. | Procedure or surgery | Tubularized Incised Plate Repair (TIP) |
Primary outcome
Complication-Free Rate
Time frame: 3 months after primary hypospadias repair
The proportion of participants without postoperative complications, including urethrocutaneous fistula, meatal stenosis, glanular dehiscence, or other complications, at 3 months after the primary repair. Participants were classified according to their current complication status before any revision surgery.
2 secondary outcomes
Complication-Free Rate at 12 Months
Time frame: 12 months after primary hypospadias repair
Hypospadias Objective Scoring Evaluation (HOSE) Score
Time frame: 3 and 12 months after primary hypospadias repair
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 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, including baseline characteristics, intraoperative measurements, complications, revision status, and outcome scores, may be shared.
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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.
Amr K. Salama, PhD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topography Guided Repair and Tubularized Incised Plate Repair in people with Distal Hypospadias Repair, run by Alexandria 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 30 Sep 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?
Complication-Free Rate (time frame: 3 months after primary hypospadias repair). 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 Sep 2026.