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Recruiting NCT04526353

Early Oxybutinin Treatment for Boys With Posterior Urethral Valves

Conditions: Male Urogenital Diseases

Sex: Male
Ages: 3 Months – 6 Months
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: University Hospital, Bordeaux

Location: CHU de Bordeaux Bordeaux

Summary

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. To our knowledge, no comparative study of the evolution of valve bladders with or without treatment has been carried out to date. Anticholinergic treatment, although it may be beneficial in patients with abnormal bladder function, such as the neurologic bladders ( in Spina Bifida) for example, may have side effects and may not be of benefit for this valve population. The evolution of the valves could be spontaneously favorable. This study would be the first randomized clinical trial of early therapeutic drug intervention in the posterior urethral valve population.

Eligibility Criteria

Inclusion 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 (\

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Source: ClinicalTrials.gov (NCT04526353). StuddyBuddy aggregates publicly available trial information.