EARLY OXYBUTININ TREATMENT FOR BOYS WITH POSTERIOR URETHRAL VALVES

PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF EARLY OXYBUTININ TREATMENT FOR BOYS WITH POSTERIOR URETHRAL VALVES - PRETIPUV

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004417-13-FR

Enrollment

Registered

2020-01-21

Start date

2020-06-02

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

POSTERIOR URETHRAL VALVES

Interventions

Product Name: pms-OXYBUTYNIN Product Code: pms-OXYBUTYNIN Pharmaceutical Form: Syrup INN or Proposed INN: OXYBUTYNIN CAS Number: 5633-20-5

Eligibility

Sex/Gender

Male

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: To evaluate the safety pharmacokinetic of oxybutynin To evaluate the safety profile of oxybutynin in boys with PUV To compare the incidence of urinary tract infection in boys with or without treatment To estimate the compliance with oxybutynin treatment To compare Sonographic changes between both groups ;Primary end point(s): composite endpoints where the success of treatment at 9 months after inclusion is defined by the association of: - Voiding pressure 10mL/cmH2O A failure of treatment will be defined as the absence of at least one of these outcomes. In presence of a pressure pop-off mechanism, only voiding pressure and bladder volume will be analyzed. ;Timepoint(s) of evaluation of this end point: at 9 months after inclusion	—

Measure

Time frame

Main Objective: 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;Secondary Objective: To evaluate the safety pharmacokinetic of oxybutynin To evaluate the safety profile of oxybutynin in boys with PUV To compare the incidence of urinary tract infection in boys with or without treatment To estimate the compliance with oxybutynin treatment To compare Sonographic changes between both groups ;Primary end point(s): composite endpoints where the success of treatment at 9 months after inclusion is defined by the association of: - Voiding pressure 10mL/cmH2O A failure of treatment will be defined as the absence of at least one of these outcomes. In presence of a pressure pop-off mechanism, only voiding pressure and bladder volume will be analyzed. ;Timepoint(s) of evaluation of this end point: at 9 months after inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): - Proportion and type of adverse events in each group - Incidence of urinary tract infections in each group - Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption (questionnaire) - Sonographic changes will be expressed as a degree of hydronephrosis at 12-13 months of life (9 months treatment) - Pharmacokinetic samples (6 points from Cmin to H+3h) at month 3, 6 and 12 of life will be used to study and determine the pharmacokinetic parameters (AUC, Cmax, Cmin, half-life) of oxybutynin and desethyloxybutynin (metabolite) in treated boys over treatment ;Timepoint(s) of evaluation of this end point: at month 3, 6 and 12 of life	—

Measure

Time frame

Secondary end point(s): - Proportion and type of adverse events in each group - Incidence of urinary tract infections in each group - Compliance with treatment will be evaluated through the proportion of oxybutynin treatment interruption (questionnaire) - Sonographic changes will be expressed as a degree of hydronephrosis at 12-13 months of life (9 months treatment) - Pharmacokinetic samples (6 points from Cmin to H+3h) at month 3, 6 and 12 of life will be used to study and determine the pharmacokinetic parameters (AUC, Cmax, Cmin, half-life) of oxybutynin and desethyloxybutynin (metabolite) in treated boys over treatment ;Timepoint(s) of evaluation of this end point: at month 3, 6 and 12 of life

—

Countries

France

Contacts

Public ContactClinical Trials Manager

CHU de Bordeaux

aurore.capelli@chu-bordeaux.fr33557820877

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026