CompletedNot Applicable

Randomized Trial Of Urethroplasty With Stent Versus Without Stent For Hypospadias

Pakistan110 participantsStarted 2025-05-25

Plain-language summary

Hypospadias is a birth condition in which the urine opening is on the underside of the penis. Surgery (urethroplasty) is the standard treatment. Surgeons sometimes leave a small tube ("stent") inside the new urine passage after surgery, but it is unclear whether using a stent affects the risk of a common complication called a urethrocutaneous fistula (a small leak from the new urethra to the skin). This study will compare two routine surgical approaches for boys 1-12 years old with distal or mid-penile hypospadias who need urethroplasty: (1) surgery with a temporary stent and (2) surgery without a stent. Children will be randomly assigned to one of the two groups. All surgeries will be performed by a consultant pediatric surgeon using a standardized technique, and all children will receive usual postoperative care. Families will return for follow-up at 2, 6, and 12 weeks after surgery. At these visits, the team will check for fistula using a simple saline test and record any other concerns. We aim to learn which approach leads to fewer complications, less discomfort, and fewer additional procedures for children undergoing hypospadias repair.

Who can participate

Age range

1 Year – 12 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Distal or mid-penile hypospadias planned for urethroplasty
. Parent/guardian provides written informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Urethrocutaneous Fistula at 12 Weeks After Urethroplasty

Timeframe: twelve weeks post operation

Trial details

NCT IDNCT07243457

SponsorChildren's Hospital and Institute of Child Health, Multan

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-20

View on ClinicalTrials.gov More Hypospadias trials