EARLY OXYBUTININ TREATMENT FOR BOYS WITH POSTERIOR URETHRAL VALVES

Phase 1

• Conditions: POSTERIOR URETHRAL VALVES; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2019-004417-13-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Boys
- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified