Early oxybutynin treatment for boys with posterior urethral valves
Official title: Prospective Randomized Clinical Trial of Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
Run by University Hospital, Bordeaux · NCT04526353 · Data updated 2026-11-12
This trial tests whether starting the anticholinergic drug oxybutynin early in boys with posterior urethral valves can improve bladder function compared with not treating.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 3 Months to 6 Months |
| Sex | Men only |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Status | Recruiting |
| Started | September 10, 2020 |
| Main results expected | February 2028 |
| Study ends | September 10, 2028 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT04526353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Boys aged 3 to 6 months who had valve resection within the first 3 months of life and show abnormal urodynamics after resection.
✕Probably not a fit
Children with normal urodynamics after resection or those who cannot tolerate oxybutynin may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2 randomized study enrolling boys aged 3 to 6 months who have had valve resection within the first 3 months of life and abnormal bladder function on urodynamics. Participants are assigned to receive oxybutynin syrup or no anticholinergic treatment, to determine the effect on bladder dynamics and outcomes. The study uses prospective, controlled comparison to evaluate early pharmacologic intervention in a non-neurologic bladder population. Outcomes focus on urodynamic parameters and clinical bladder function, with careful monitoring for drug-related side effects. The trial is led by University Hospital, Bordeaux, and conducted at CHU de Bordeaux in France.
Why it matters
Potential benefit: If successful, early oxybutynin could improve bladder function and potentially reduce long-term renal risk for boys with posterior urethral valves.
How similar studies have gone: There has been limited prior work; one small non-randomized study suggested potential benefits but lacked a control group, making this randomized trial novel in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU de Bordeaux
Bordeaux, France Recruiting
Study contacts
- Principal investigator: Laurent L FOURCADE, MD — University Hospital, Limoges
- Study coordinator: Luke L HARPER, MD
- Email: luke.harper@chu-bordeaux.fr
- Phone: 05 56 79 56 17
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.