ClinicalTrials.gg
Enrolling by invitationNCT07934147Updated Nov 12, 2026

Comparison of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Pediatric Patients With Versus Without Post-operative Neo-Urethral Dilatation-A Randomized Controlled Trial

An interventional study of Dilatation and No dilatation in Hypospadias and Fistula Stenosis, sponsored by University of Faisalabad. Enrolling by invitation at 1 site in Pakistan. Open to male participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Faisalabad · Not applicable, Interventional, and Prevention

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
6 Months to 15 Years
Sex
Male
01

Study summary

This Study with compare that how will urethral dilatation post hypospadias surgery will effect formation of fistula formation

Read the detailed description

Hypospadias is presence of urethral opening on undersurface of penis. Repair of hypospadias is associated with formation of fistula. In this study we will compare how will urethral dilatation will effect fistula formation rate and vice versa.

02

Conditions studied

  • Hypospadias
  • Fistula Stenosis

Keywords

  • Hypospadias
  • Fistula
  • Urethral dilatation
03

In context

Hypospadias

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

This study's planned enrollment of 150 is above the median of 70 across 97 interventional studies indexed under Hypospadias.

Browse Hypospadias studies →

Lead sponsor

University of Faisalabad is the lead sponsor of 87 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 15 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

    • Male children aged 6 months to 15 years

      • Diagnosed cases of hypospadias
      • Undergoing primary hypospadias repair
      • from parents/guardians

Exclusion criteria

Exclusion Criteria:

    • Previous hypospadias surgery

      • Associated disorders of sexual development
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
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Neo- urethral Dilataion

    Neo urethral Dilatation will be done in one group of patients

    Other: Dilatation

  • Experimental
    No Neo Urethral Dilatation

    No Neo urethral dilatation will be done in second group

    Other: No dilatation

Interventions

  • OtherDilatation

    Neo urethral dilatation will done in one group

  • OtherNo dilatation

    No dilatation will be done in second group

06

What researchers measure

Primary outcomes

  1. Fistula Fromation

    We will observe that which what will be rate of fistula formation in both groups

    Time frame: UpTo 6 months after surgery

07

Study locations

1 site
  • University medical and Dental college/ The university of Faisalabad
    Faisalabad, Punjab Province 38000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

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

Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.

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 planned 12 months is below 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
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Nov 12, 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.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

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
NCT07934147
Lead sponsor
University of Faisalabad
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Nov 12, 2026

Oversight

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

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