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New treatment option for Male Urogenital Diseases
Official title Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
ClinicalTrials.gov ID: NCT04526353
What this study is testing
What is Oxybutynin 1 mg/ml Syrup?
Oxybutynin 1 mg/ml Syrup is an investigational medicine, given as an once-daily, being studied as a potential treatment for male urogenital diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 6, men only
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
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- Holders of parental authority affiliated to French national health insurance
- With informed consent signed by holders of parental authority
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
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, 3 months to 6 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.