ClinicalTrials.gg
CompletedNCT07832760DPH repairUpdated Sep 30, 2026

Topography Guided Repair Versus TIP for Distal Hypospadias

An interventional study of Topography Guided Repair and Tubularized Incised Plate Repair in Distal Hypospadias Repair, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to male participants aged 6 Months to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Dec 2023, registered Sep 2026).
Updated Sep 30, 2026Title changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
6 Months to 16 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Hypospadias with a site in Egypt — 12 open to participants now, 13 under way, none of them phase 3. Hypospadias · Egypt.

Enrollment
8th of 33
101 · median 69
Started
2023
with 6 others
No phase
29 of 36
11 open now
Registered
36th of 36
by date
Lead sponsor
1 of 36
Alexandria University

Among the 36 studies in Hypospadias with a site in Egypt, this one is the 8th largest by enrollment of the 33 interventional ones that give a count, is one of 7 that started in 2023, is one of 29 with no phase, and was the 36th registered.

Hypospadias

123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.

Browse Hypospadias studies →

Open to participants now

12 of the 36 studies in Hypospadias with a site in Egypt are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 20 Hypospadias studies recruiting now, 4 (20%) set no upper age limit and 16 (80%) stop at 75 or younger; 18 take children under 18; 3 take healthy volunteers.

This study: 6 Months to 16 Years · male · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Distal Hypospadias Repair

Browse trials for

Keywords

  • DPH
  • Topographic repair
  • TIP
04

Who can participate

Ages eligible
6 Months to 16 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children younger than 16 years with previously untreated distal penile hypospadias.
  • Uncircumcised patients.
  • Parent or caregiver able to provide written .

Exclusion criteria

Exclusion Criteria:

  • Previous hypospadias repair.
  • Previous circumcision.
  • Proximal hypospadias diagnosed before surgery.
  • Penile curvature of 30 degrees or greater.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Topography-Guided Repair (TGR)

    Distal Hypospadias Repair using the topographic anatomical repair technique

    Procedure: Topography Guided Repair

  • Active comparator
    Tubularized Incised Plate Repair (TIP)

    Distal Hypospadias Repair using the TiP technique

    Procedure: Tubularized Incised Plate Repair

Interventions

  • ProcedureTopography Guided Repair

    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.

  • ProcedureTubularized Incised Plate Repair

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after primary hypospadias repair

Secondary outcomes

  1. 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.

    Time frame: 12 months after primary hypospadias repair

  2. 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.

    Time frame: 3 and 12 months after primary hypospadias repair

07

Study locations

1 site
  • Alexandria Faculty of Medicine
    Alexandria, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the published results, including baseline characteristics, intraoperative measurements, complications, revision status, and outcome scores, may be shared.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2023 to primary completion in Sep 2025, 20 months.

Of 60 non-industry interventional studies with no phase under Hypospadias, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's 20 months is above that.

Counting every sponsor, half of 60 studies reached it within 15 months; a quarter within 8 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartActual
Dec 20, 2023
Primary completionActual
Sep 8, 2025
CompletionActual
Jun 8, 2026
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Title
Topography Guided Repair Versus TIP for Distal Hypospadias: A Randomized Pilot Trial
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Title Topography Guided Repair Versus TIP for Distal Hypospadias: A Randomized Pilot Trial
    + 1 other change: conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07832760
Responsible party
Amr Salama (Prof., Alexandria University) — Principal investigator
First posted
Sep 22, 2026
Start date
Dec 20, 2023
Primary completion
Sep 8, 2025
Completion
Jun 8, 2026
Last update
Sep 30, 2026

Study contacts

Amr K. Salama, PhD
principal investigator · Alexandria University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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