Could a common bladder drug help boys with rare birth defect?

NCT ID NCT04526353

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving oxybutynin syrup early (starting at 3-6 months old) can improve bladder function in boys born with posterior urethral valves, a condition that blocks urine flow. Fifty boys who had valve surgery will be randomly assigned to receive either oxybutynin or no additional treatment. The goal is to see if the drug helps lower bladder pressure, increase bladder capacity, and reduce infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: oxybutynin syrup
What this could lead to: If successful, this could provide an effective early treatment to improve bladder function and reduce long-term complications in boys with posterior urethral valves.
What could go wrong: This is a small Phase 2 trial with only 50 participants, so results may not apply broadly. Oxybutynin can cause side effects like dry mouth or constipation, and it may not benefit all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 6 months

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Boys * Aged 3 to 6 months * Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life * Children who have had their valve resection at least 3 months before inclusion * Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (\>60cm H2O)/ small capacity bladder (\<70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (\<10ml/cmH2O)/ * Holders of parental authority affiliated to French national health insurance * With informed consent signed by holders of parental authority Exclusion Criteria: * Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment * Boys in whom urodynamic assessment is not possible for medical or anatomical reasons * Boys requiring dialysis before the age of 3 months * Contra-indication to oxybutynin such as hypersensitivity to oxybutynin or any of the excipients, digestive obstruction, occlusive or sub-occlusive syndrome, megacolon, digestive stasis, intestinal atony, paralytic ileus, ulcerative colitis, Hemorrhagic rectocolitis, Crohn's disease, Inflammatory bowel disease, Inflammatory organic colopathy, myasthenia, congenital glaucoma

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Male urogenital diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Male Urogenital Diseases posterior urethral valve

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Male urogenital diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a common bladder drug help boys with rare birth defect?

What the study statuses mean