EUCTR2019-004417-13-FRActive, not recruitingPhase 1
PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF EARLY OXYBUTININ TREATMENT FOR BOYS WITH POSTERIOR URETHRAL VALVES - PRETIPUV
CHU de Bordeaux0 sites50 target enrollmentStarted: January 21, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •- Aged 3 to 5 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 3- 5 months of age
- •- 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)/
- •- Holders of parental authority affiliated to French national health insurance
- •- With informed consent signed by holders of parental authority
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 (e.g. congenital glaucoma)
Investigators
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