NCT04526353 Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
| NCT ID | NCT04526353 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Bordeaux |
| Condition | Male Urogenital Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-09-10 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2020-09-10 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been any clear studies on the subject. To our knowledge, no comparative study of the evolution of valve bladders with or without treatment has been carried out to date. Anticholinergic treatment, although it may be beneficial in patients with abnormal bladder function, such as the neurologic bladders ( in Spina Bifida) for example, may have side effects and may not be of benefit for this valve population. The evolution of the valves could be spontaneously favorable. This study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.
Eligibility 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
Contact & Investigator
Laurent L FOURCADE, MD
PRINCIPAL INVESTIGATOR
University Hospital, Limoges
Frequently Asked Questions
Who can join the NCT04526353 clinical trial?
This trial is open to male participants only, aged 3 Months or older, up to 6 Months, studying Male Urogenital Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04526353 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04526353 currently recruiting?
Yes, NCT04526353 is actively recruiting participants. Contact the research team at luke.harper@chu-bordeaux.fr for enrollment information.
Where is the NCT04526353 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT04526353 clinical trial?
NCT04526353 is sponsored by University Hospital, Bordeaux. The principal investigator is Laurent L FOURCADE, MD at University Hospital, Limoges. The trial plans to enroll 50 participants.