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PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF EARLY OXYBUTININ TREATMENT FOR BOYS WITH POSTERIOR URETHRAL VALVES - PRETIPUV -
EU CTIS ID: 2024-515844-22-00
What this study is testing
To estimate the effect of oxybutynin on urodynamic evolution of bladder function (bladder compliance, bladder volume, peak voiding pressure) in boys after posterior valve ablation
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Boys aged 3 to 6 months
- Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life
- Having undergone urodynamic studies between 10 weeks and 6 months of age and showing 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)/
- Affiliated person or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
You likely can't join if
- Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment
- Boys requiring dialysis before the age of 3 months.
- Boys who cannot undergo urodynamic testing for medical or anatomical reasons
- Boys with severe decreased gastrointestinal motility conditions
- Contra-indication to oxybutynin treatment such as hypersensitivity to oxybutynin ou 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.